Kit of parts providing components implantable in a patient to adapt a neopenis of the patient for penetrative intercourse

ABSTRACT

A kit of parts includes components implantable in a patient to adapt a neopenis of the patient for penetrative intercourse. The kit of parts includes an implantable support, an implantable penile prosthesis, and an artificial glans penis. When implanted, the implantable support orients the implantable penile prosthesis and the artificial glans penis in an anatomically natal penis position that is adapted for penetrative intercourse.

BACKGROUND

Gender is an internal sense of being male or female. Sex is a physicalcondition of the body that is a combination of bodily characteristicsincluding chromosomes, hormones, internal and external reproductiveorgans, and secondary characteristics. Transgender is an adjective todescribe people whose identity, or expression, or behavior, or sense ofself does not conform to their sex as assigned at birth. Genderaffirming surgery is a procedure to surgically alter a patient's body sothat features of the physical body align with the patient's genderidentity.

Some people who are assigned the female sex at birth have a male genderidentity and desire to have surgery to provide their body with a genitalappearance, for example through a phalloplasty procedure to provide theperson with a neophallus, so that their physical characteristics conformwith their sense of self.

Some natal males experience a birth defect or an injury to their penisand have a new penis reconstructed (a neopenis), which can include aneophallus formed from tissue and a prosthetic implanted in theneophallus.

Surgeons and patients would welcome improved penile implant systems andmethods of implanting a penile prosthetic in a neophallus.

SUMMARY

Devices, penile implant systems, and methods of implanting the devicesand the penile implants are disclosed to provide a person who isassigned the female sex at birth with a genital appearance that conformswith their male gender identity.

Devices, penile implant systems, and methods of implanting the devicesand the penile implants are disclosed to provide a person who wasassigned the female sex at birth with a neopenis that is situatedanatomically in a natal penis position and that is suitable forpenetrative intercourse.

A neophallus implant, a neophallus implant system, and a method ofimplanting a penile prosthetic in a neophallus are disclosed to providea person who is assigned the female sex at birth with a natal maleappearance that conforms with their male gender identity and allows forpenetrative intercourse.

Devices, penile implant systems, and methods of implanting the devicesand the penile implants are disclosed to construct a neopenis for anatal male who has suffered a traumatic injury to his penis.

A neophallus implant, a neophallus implant system, and a method ofimplanting a penile prosthetic in a neophallus are disclosed toconstruct a neopenis for a natal male who has suffered a traumaticinjury to his penis.

Penile implants for the natal male penis are generally linear and sizedfor insertion linearly from the existing crus penis recess through thecorpora cavernosum. The corpora cavernosa, the crus penis, and thetunica of the natal male penis provide support and resist bending of theimplanted penile implant.

A trans-male pelvis is a pelvis of a person who was assigned the femalesex at birth that has been surgically modified to receive a neophallusor a neopenis. The trans-male anatomy does not have corpora cavernosa,the crus penis, or the tunica. Thus, the penile implants for the natalmale are not well suited for implantation into the pelvis of thetrans-male. One consequence of this anatomical reality for thetrans-male pelvis is that a penile implant designed for the natal malewill not have adequate support to allow for penetrative intercourseafter implantation into the trans-male. Some approaches have been tosimply attach a penile implant designed for the natal male directly tothe anterior pelvis, which results in a neopenis that is in ananatomically non-natural position (e.g., placed too far cephalad,resulting in a neopenis that is undesirably “too high up”). Embodimentsprovide supports, implants, devices, systems, and methods that allow theimplantation of a penile implant into a trans-male pelvis in ananatomical natal male orientation to provide a natal male appearancethat conforms with a desired male gender identity and to facilitatepenetrative intercourse.

Embodiments provide an implant that forms an artificial crus penis thatis implantable in a person that was assigned the female sex at birth,where the artificial crus penis is adapted to maintain an implantedpenile prosthetic (inflatable or non-inflatable) anatomically in a natalpenis position that orients a proximal end of the prosthetic inferiorand posterior to the pubic body. The artificial crus penis provides afoundational support for a penile prosthetic to provide the trans-maleperson with a neopenis that is situated anatomically in the sameposition as a natal penis suitable for penetrative intercourse.

In embodiments, implantable apparatuses and method of implanting theapparatuses are disclosed that provide a person assigned the female sexat birth with a penis.

In one embodiment, an implantable support provides a reinforcedfoundation for a penile prosthetic that is implanted in natal femaleanatomy. The implantable support provides the natal female anatomy witha supporting, suspensory ligament structure that approximates theligament present in natal male anatomy. These suspensory ligaments inthe natal male originate near the pubic symphysis and attach at the baseof the penis. The implantable support replicates the suspensoryligaments in the form of an artificial ligament that provides a morerealistic appearance for the neophallus with improvedresponsiveness/input/feeling during thrusting associated withpenetrative intercourse.

Embodiments provide an implant that forms an artificial crus penis thatis implantable in a male having a penis injury, where the artificialcrus penis is adapted to maintain an implanted penile prosthetic in ananatomically proper position for a natal male that orients a proximalend of the prosthetic inferior and posterior to the pubic body. Theartificial crus penis provides a foundational support for a penileprosthetic to provide the male with a neopenis that is situatedanatomically in the same position as an uninjured natal penis suitablefor penetrative intercourse.

One embodiment of a neophallus implant includes a distal portion that isadapted for insertion into tissue of a neophallus to provide theneophallus with an erection adapted for penetrative intercourse; a firstproximal portion and a separate second proximal portion; and a transferjoint. The transfer joint has a distal end connected to the distalportion of the neophallus implant, a first proximal end connected to thefirst proximal portion of the neophallus implant, a second proximal endconnected to the separate second proximal portion of the neophallusimplant, with a body of the transfer joint extending between the distalend, the first proximal end, and the second proximal end. The body ofthe transfer joint has a fixed bend that is adapted to orient the firstproximal portion and the separate second proximal portion alongside adescending pubic ramus on either side of a pubic arch of a trans-malepelvis. One effect of the fixed bend is to limit motion and constrainmovement of the neophallus implant after implantation.

An embodiment of the neophallus implant provides at least the distalportion of the neophallus implant is an inflatable penile prosthetic,one effect of which is to provide the person with an erection, where theperson can control the hardness and the girth of the erection through anamount of liquid inflated into the distal portion.

An embodiment of the neophallus implant provides a liquid port connectedto one of the first proximal portion and the second proximal portion,one effect of which is to reduce the number of inflation ports from twodown to one.

An embodiment of the neophallus implant the distal portion of theneophallus implant as an inflatable penile prosthetic and the firstproximal portion and the second proximal portion of the neophallusimplant are not inflatable. The effect is to provide improved comfortwhere the proximal portions engage with the ramus.

An embodiment of the neophallus implant provides the distal portion ofthe neophallus implant is an inflatable penile prosthetic having one andonly one inflatable cavity, the effect of which is to provide a widegirth implant adapted for insertion into a neophallus that does not havetunicae.

An embodiment of the neophallus implant provides a diameter of thedistal portion of the neophallus implant is larger than a diameter ofthe first proximal portion and a diameter of the second proximalportion. The effect of the smaller diameter proximal portions is toenhance comfort after implantation while the distal portion providesenhanced girth.

An embodiment of the neophallus implant provides the distal portion asan inflatable penile prosthetic having a first inflatable cavity coupledalong a septum to a second inflatable cavity. The effect is to have awider distal portion with two sections that are attached/integrated asone part.

An embodiment of the neophallus implant the neophallus implant as amonolithically formed single unit including the transfer joint, thedistal portion, the first proximal portion of the neophallus implant,and the second proximal portion of the neophallus implant. The effect isto provide a Y-shaped neophallus implant that has limited movement andresist axial thrust forces associated with penetrative intercourse.

An embodiment of the neophallus implant provides the fixed bend in thetransfer joint to orient the first proximal portion of the neophallusimplant at an angle in a range from 80-110 degrees relative to thesecond proximal portion of the neophallus implant to adapt the firstproximal portion and the second proximal portion of the neophallusimplant to align with a female pubic arch. The effect of the angle is toadapt the proximal portions to lie alongside the narrower pubic openingof the female pelvis.

An embodiment of the neophallus implant provides the first proximalportion and the second proximal portion of the neophallus implant have aflat profile with a rectangular cross-sectional shape. The effect of theflat profile is to allow the proximal portions to lie flat andcomfortably alongside the descending rami.

An embodiment of the neophallus implant provides the first proximalportion and the second proximal portion are each a solid componenthaving a circular lateral cross-sectional shape that tapers to convergeto a proximal end. The effect is to provide proximal ends that areeasily inserted between tissue around or near the rami.

An embodiment of the neophallus implant provides the transfer joint, thedistal portion, the first proximal portion, and the second proximalportion combine to provide a Y-shaped neophallus implant. The Y-shapedneophallus implant limits and constrains movement of the implanteddevice, particularly during penetrative intercourse. One embodiment ofan implant includes a distal tubular portion that is adapted forinsertion into a neophallus and is operable to provide the neophalluswith an erection adapted for penetrative intercourse; a first proximalportion that is adapted for attachment to tissue of a descending ramusof a pelvis; and a transfer joint having a distal end connected to thedistal tubular portion of the implant, a first proximal end connected tothe first proximal portion of the implant, and a body extendingcontinuously from the distal end to the first proximal end. The body ofthe transfer joint has a fixed bend, one effect of which is to orientthe distal tubular portion of the implant at an obtuse angle relative tothe first proximal portion of the implant, which provides a trans-malewith a neopenis having an orientation of that of a penis of a natalmale. Benefits and advantages of the implant include the formation of aneopenis that is adapted for penetrative intercourse; providing a personwho is assigned the female sex at birth with a genital appearance thatconforms with their male gender identity; and providing a person who wasassigned the female sex at birth with a neopenis that is situatedanatomically in a natal penis position and that is suitable forpenetrative intercourse.

An embodiment of the implant has a second proximal portion that isadapted for attachment to tissue of a second descending ramus of thepelvis, with the second proximal portion of the implant connected to asecond proximal end of the transfer joint. The fixed bend in thetransfer joint has the effect of orienting the first proximal portion ofthe implant at an angle of 110 degrees or less relative to the secondproximal portion of the implant, and this angle conforms with thegenerally wider female pubic arch of the trans-male pelvis. In oneembodiment, the fixed bend in the transfer joint has the effect oforienting the first proximal portion of the implant at an angle in arange from 80-110 degrees relative to the second proximal portion of theimplant, and this angle conforms with the generally wider female pubicarch of the trans-male pelvis.

An embodiment of the implant has the transfer joint monolithicallyformed to the first proximal portion of the implant and the secondproximal portion of the implant, which ensures the desired orientationof the implant and provides rigidity. Monolithically formed means formedas a single piece, a one-and-only-one piece implant formed to includetwo bifurcated proximal portions and a distal portion.

An embodiment of the implant has the fixed bend in the transfer joint atan angle of between 55-70 degrees relative to the second proximalportion of the implant, one effect of which is to align the firstproximal portion and the second proximal portion of the implant with afemale pubic arch.

An embodiment of the implant has a liquid port connected to the firstproximal portion, and the distal tubular portion is a liquid inflatableprosthetic, one effect of which is to provide the neopenis with areversible erection. A suitable liquid source, such as a reservoir, anda pump to move the liquid, are connected to the liquid port andimplanted in the body of the trans-male.

An embodiment of the implant has the distal tubular portion and thefirst proximal portion linearly aligned (straight along a onelongitudinal axis), one effect of which is to securely fit the distaltubular portion in the neophallus in a natal male position and tosecurely fit the first proximal portion along the ramus for improvedcomfort.

An embodiment of the implant provides the distal tubular portion as amalleable prosthetic, one effect of which is to provide the neopeniswith a user-reversible erection achieved by bending the implant with ahand.

An embodiment of the implant provides the distal tubular portion as amalleable prosthetic and the first proximal portion is a plastic rod,one effect of which is to provide the neopenis with a comfortableimplant and a user-reversible erection.

An embodiment of the implant provides the distal tubular portion as amalleable prosthetic and the first proximal portion is a metal rod, oneeffect of which is to provide the neopenis with a comfortable implantand a user-reversible erection.

An embodiment of the implant provides the distal tubular portion as amalleable prosthetic and the first proximal portion is also a malleableprosthetic, one effect of which is to provide the neopenis with acomfortable implant and a simple user-reversible erection.

An embodiment of the implant provides the distal tubular portion as aninflatable prosthetic having a first inflatable cavity coupled along aseptum to a second inflatable cavity, one effect of which is to increasethe girth of the neopenis.

One embodiment of an implant includes a distal tubular portion that isadapted for insertion into tissue a neophallus to provide the neophalluswith an erection adapted for penetrative intercourse; a first proximalportion that is adapted for attachment to tissue of a descending ramusof a trans-male pelvis; and a transfer joint having a distal endconnected to the distal tubular portion of the implant, a first proximalend connected to the first proximal portion of the implant, and a bodyextending between the distal end and the first proximal end. The body ofthe transfer joint having a fixed bend, one effect of which is to adaptand orient the distal tubular portion at a female pubic arch half anglerelative to the first proximal portion to so adapt the implant toprovide a neopenis having a conformation (location and appearance) ofthat of a natal male penis.

An embodiment of the implant provides a second proximal portion that isadapted for attachment to tissue of a second descending ramus of thetrans-male pelvis, with the second proximal portion of the implantconnected to a second proximal end of the transfer joint. The fixed bendin the transfer joint has the effect of maintaining the first proximalportion of the implant at a female pubic arch angle relative to thesecond proximal portion of the implant to provide a comfortable natalmale conformation.

An embodiment of the implant provides a liquid port connected to thefirst proximal portion, and the distal tubular portion is a liquidinflatable prosthetic, one effect of which is to provide the trans-malewith a comfortable and reversible erection.

An embodiment of the implant provides the distal tubular portion and thefirst proximal portion as linear and aligned to be straight along alongitudinal axis, one effect of which provides an easy implantationapproach for the surgeon and a more comfortable implant for thetrans-male.

An embodiment of the implant provides the distal tubular portion as amalleable prosthetic, and the first proximal portion is one of a plasticrod, a metal rod, and a malleable prosthetic to provide the trans-malewith a comfortable and reversible erection.

An embodiment of the implant provides the distal tubular portion as aninflatable prosthetic having a first inflatable cavity coupled along aseptum to a second inflatable cavity, one effect of which is to increasethe girth of the neopenis.

One embodiment provides a method of implanting a penile implant, wherethe method includes providing a neophallus implant having a transferjoint connected between a distal tubular portion and a first proximalportion; forming a neophallus; inserting the distal tubular portion intothe neophallus; surgically securing the first proximal portion to tissueof a trans-male pelvis; and configuring the distal tubular portion toprovide the neophallus with an erection in a neopenis of the trans-malepelvis.

An embodiment of the method includes surgically securing the firstproximal portion to the tissue of the trans-male pelvis by implanting anartificial crus penis recess into the trans-male pelvis.

An embodiment of the method includes aligning a neourethra of thetrans-male pelvis with the distal tubular portion inside of theneophallus.

Implantable apparatuses and method of implanting the apparatuses aredisclosed that provide a person with a neopenis including a penileprosthetic implanted into a neophallus. The neopenis is situatedanatomically in the same position as a natal penis suitable forpenetrative intercourse.

Embodiments provide a neophallus implant having a Y-shaped penileprosthetic including: a distal tubular portion that is adapted forinsertion into tissue to provide the tissue with an erection adapted forpenetrative intercourse; a first proximal portion that is adapted forattachment to a descending ramus of a pelvis; a second proximal portionthat is adapted for attachment to a second descending ramus of thepelvis; and a transfer joint having a distal end adapted for attachmentto the distal tubular portion of the implant, a first proximal endadapted for attachment to the first proximal portion of the implant, asecond proximal end adapted for attachment to the second proximalportion of the implant, and a body extending continuously in a Y-shapefrom the distal end to the first proximal end and the second proximalend. The Y-shaped penile prosthetic has, along with other features, theeffect of having two proximal portions that are attachable to the pelvicrami structure, with a distal portion that has a conformation thatorients the external part of the penis on a center line of thetrans-male person.

Embodiments provide a penile implant system configured to provide aperson with a neopenis, where the penile implant system includes apenile prosthetic having a shaft connected between a distal end portionand a proximal end portion, with the distal end portion sized forimplantation into a neophallus of the neopenis; and an implantablesupport that is attachable to a descending ramus of a pelvis to providean artificial crus penis recess. The proximal end portion of the penileprosthetic is adapted for placement inside of the artificial crus penisrecess. One effect of the implantable support is to locate the neopenisanatomically on a trans-male body in a natal penis location.

In embodiments, the implantable support can include a base and anartificial fundiform suspensory ligament located between the base andthe artificial crus penis recess. One effect of the artificial fundiformsuspensory ligament is to locate the neopenis anatomically below thepubic body/pubic symphysis of a trans-male body in a suspended and natalpenis location.

Embodiments provide a penile implant system configured to provide aperson with a neopenis, where the penile implant system includes apenile prosthetic having a distal end portion that terminates at adistal end and a proximal end portion that terminates at a proximal end,with the penile prosthetic sized for surgical implantation into aneophallus of the neopenis; and an implantable support provided separatefrom the penile prosthetic. The implantable support includes: a proximalattachment tab connected to the implantable support and configured forattachment to a descending ramus of the person, a distal attachment tabconnected to the implantable support and configured for attachment toone of a pubic body and a pubic symphysis of the person, and anartificial crus penis recess connected to the implantable support at alocation between the proximal attachment tab and the distal attachmenttab. The artificial crus penis recess sized to receive the proximal endportion of the penile prosthetic. One effect of the implantable supportis to locate the neopenis anatomically on a trans-male body in a natalpenis location. The implant system can include an artificial ligamentconnected to the artificial crus penis recess. One effect of theartificial ligament is to locate the neopenis anatomically below thepubic body of a trans-male body in a suspended and natal penis location.

One embodiment provides a penile implant system configured to provide aperson assigned the female sex at birth with a neopenis, where thepenile implant system includes a penile prosthetic having a distal endportion that terminates at a distal end and a proximal end portion thatterminates at a proximal end, with the penile prosthetic sized forsurgical implantation into a neophallus of the person assigned thefemale sex at birth; and an implantable support provided separate fromthe penile prosthetic. The implantable support includes: a base that isattachable to a pelvis of the person assigned the female sex at birth,an artificial crus penis recess connected to the base, and an artificialligament connected to the artificial crus penis recess. One effect ofthe implantable support is to locate the neopenis anatomically on atrans-male body in a natal penis location. The implant system caninclude an artificial ligament connected to the artificial crus penisrecess. One effect of the artificial ligament is to locate the neopenisanatomically below the pubic body of a trans-male body in a suspendedand natal penis location.

Embodiments provide a penile implant system configured to provide aperson assigned the female sex at birth with a neopenis. The penileimplant system includes a penile prosthetic having a distal end portionthat terminates at a distal end and a proximal end portion thatterminates at a proximal end, with the penile prosthetic sized forinsertion into a neophallus of the person assigned the female sex atbirth; and an implantable support provided separate from the penileprosthetic. The implantable support includes: a base that is attachableto a pelvis of the person assigned the female sex at birth, and anartificial crus penis recess connected to the base. The artificial cruspenis recess is sized to receive the proximal end portion and theproximal end of the penile prosthetic. One effect of the implantablesupport having the artificial crus penis recess is to locate theneopenis anatomically on a trans-male body in a natal penis location.

Embodiments of the penile implant system include an interior of theartificial crus penis recess is formed to be conical and sized toreceive a conical proximal end portion of the penile prosthetic, oneeffect of which is to ensure positive coupling of the penile prostheticto the trans-male pelvis, and to guide self-centering of the penileprosthetic inside of the recess.

Embodiments of the penile implant system include an artificial ligamentsecured between the base and the artificial crus penis recess. Oneeffect of the artificial ligament is to locate the neopenis anatomicallybelow the pubic body of a trans-male body in a suspended and natal penislocation.

Embodiments of the penile implant system include an inflatable penileprosthetic including a tubular bladder secured to the proximal endportion of the penile prosthetic, one effect of which is to allow theuser to control the firmness and girth of the erection of theneophallus.

Embodiments of the penile implant system include a malleable metal coresurrounded by a polymer cover, with the malleable metal core having acolumn strength adapted to allow penetrative intercourse with the penileimplant. The malleable aspect of the embodiment has the effect ofproviding a firm erection even for those with limited dexterity, and theerection has repeatable and satisfactory characteristics each time.

Embodiments of the penile implant system include an implant bed having atubular sleeve sized to receive the distal end and the proximal end ofthe penile prosthetic and a flap attached to the tubular sleeve, withthe flap extending a first distance in a lateral direction from thetubular sleeve and a second distance in a proximal direction from aproximal end of the sleeve. The tubular sleeve includes an accessopening that is sized to allow the penile prosthetic to be inserted intothe tubular sleeve. One effect of the tubular sleeve is to offer thesurgeon flexibility in locating the implant bed to ensure the desiredpositioning of the implant.

Embodiments of the penile implant system include a tubular sleeve isformed of a mesh fabric, one effect of which is to ensure tissueingrowth into the fabric for a positive support after implantation.

Embodiments of the penile implant system include a penile prostheticthat includes a first cylindrical shaft and a second cylindrical shaft,and an implantable support having an implant bed with a first tubularsleeve sized to receive the first cylindrical shaft and a second tubularsleeve sized to receive the second cylindrical shaft. The implant bedincludes an access opening that is sized to allow the penile prostheticto be inserted into the first tubular sleeve and the second tubularsleeve. One effect of the implant bed is to provide an artificial tunicathat supports the penile prosthetic and also allows for attachment ofthe implant to the pelvis.

Embodiments of the penile implant system include a sheet of material,with the base and the artificial crus penis recess integrally formedfrom the sheet of material to include an artificial ligament connectedbetween the base and the artificial crus penis recess. Effects of thesheet of material, including the artificial ligament, include to allowfor ease of implantation, provide effective coupling to the availablestructure of the pelvis, and provide a structure that is adapted tolocate the neopenis anatomically below the pubic body of a trans-malebody in a natal penis location.

Embodiments of the penile implant system include a sheet of materialwith a first line of stitching demarcating the base and the artificialligament, and a second line of stitching demarcating the artificialligament and the artificial crus penis recess. Effects of the stitchinginclude to provide boundaries that identify the artificial ligament andposition the artificial ligament in a suspensory orientation useful inthe desired anatomical placement of the implant.

Embodiments of the penile implant system include a plug insertable intothe artificial crus penis recess. One effect of the plug is to occupyspace to prevent tissue from growing into the recess, where the plug isadapted to be removed by the surgeon to expose the recess to receive aportion of the implant.

Embodiments of the penile implant system include a sheet of material,with the base and two of the artificial crus penis recesses integrallyformed from the sheet of material, with a first artificial ligamentconnected between the base and a first one of the two of the artificialcrus penis recess and a second artificial ligament connected between thebase and a second one of the two of the artificial crus penis recess.Effects of having two artificial crus penis recesses suspended by twoartificial ligaments are to achieve the appropriate placement andsupport of the implant on the pelvis of a trans-male, where thestructure is anatomically absent.

Embodiments of the penile implant system include a base of theimplantable support having a first flange that is attachable to a firstramus of the pelvis and a second flange that is attachable to a secondramus of the pelvis. The artificial crus penis recess is formed in thebase of the implantable support between the first flange and the secondflange. One effect of the first flange and the second flange is toprovide attachment locations for the implantable support that allows thesurgeon to selectively connect the support to the tissue of a trans-malepelvis.

Embodiments of the penile implant system include an artificial cruspenis with a receptacle having an opening into a recess, where therecess is defined by an interior surface of the receptacle, and a ridgeis formed inside of the receptacle projecting away from the interiorsurface of the receptacle. When the proximal end of the penileprosthetic is superior to the ridge, the neophallus is in a flaccidstate. When the proximal end of the penile prosthetic is inferior to theridge, the penile prosthetic and the neophallus are maintained in anerect state that adapts the neopenis for penetrative intercourse. Oneeffect of the receptacle, and the ridge inside of the receptacle, is toprovide an artificial crus penis with an engagement mechanism thatallows the implant to be moved by the user between an erect position ina flaccid position.

Embodiments of the penile implant system include an implantable supportwith a tab extending from the base. The proximal end of the penileprosthetic is engaged with the tab. When the proximal end of the penileprosthetic is superior to the tab, the neophallus is in a flaccid state.When the proximal end of the penile prosthetic is inferior to the tab,the neophallus is in an erect state adapted for penetrative intercourse.One effect of an implantable support having a projecting tab is toprovide the support and engagement mechanism that allows the implant tobe moved by the user between an erect position and a flaccid position.

Embodiments of the penile implant system include an implantable supporthaving a fabric having a first lateral edge attachable to a firstobturator foramen of the pelvis and a second lateral edge attachable toa second obturator foramen of the pelvis. The artificial crus penisrecess is formed in the fabric between the first lateral edge and thesecond lateral edge. One effect of a fabric support is to provide asupport that will integrate with the tissue to provide a strongfoundation for penetrative intercourse with the implant.

Embodiments of the penile implant system include a fabric polymer meshincluding openings formed in the mesh, with the openings sized to have amean pore size of about 75 micrometers and so configured for tissuethrough-growth. One effect of selecting a mean pore size of about 75 μmis to ensure tissue growth through the support.

Embodiments of the penile implant system include an implantable supporthaving a plate having a first lateral edge attachable to a first ramusand a second lateral edge attachable to a second ramus, and theartificial crus penis recess includes a post that is formed to projectaway from the plate. The proximal end of the penile prosthetic includesa post hole that is sized to engage with the post. One effect of theplate is to provide a firm foundational backboard for the implant thatis adapted to support the implant and resist the axial forces associatedwith penetrative intercourse.

Embodiments of the penile implant system include a malleable penileprosthetic having a metal core surrounded by a polymer cover. One effectof the malleable penile prosthetic is to provide an implant that theuser can move between an erect position in a flaccid position, where theerection is uniform and repeatable.

Embodiments of the penile implant system include an inflatable penileprosthetic having a bladder that is inflatable with liquid to an erectstate having a column strength adapted to allow penetrative intercoursewith the prosthetic penis. One effect of the inflatable penileprosthetic is to allow the user to control the firmness and the girth ofthe erection.

Embodiments provide a method of providing a person with a neopenis byimplanting a penile implant in a neophallus of the person. The methodincludes providing an implant bed including an artificial crus penisrecess; securing a proximal portion of the implant bed to a descendingramus of the person; securing a distal portion of the implant bed to oneof a pubic body and a pubic symphysis of the person; locating theartificial crus penis recess inferior relative to the pubic body of theperson; inserting a penile prosthetic into the neophallus; and insertinga proximal end portion of the penile prosthetic into the artificial cruspenis recess. One effect of the method is to provide a person that doesnot have a penis, whether trans-male or through trauma, with a new penisthat can achieve an erection.

Embodiments provide a method of providing a person with a neopenis byimplanting a penile implant in a neophallus of the person. The methodincludes implanting an implantable support in the person, attaching theimplantable support to a descending ramus of a pelvis of the person, andproviding the pelvis with an artificial crus penis formed by theimplantable support; implanting a distal end portion of a penileprosthetic into a distal end portion of the neophallus; implanting aproximal end portion of the penile prosthetic into a proximal endportion of the neophallus; and coupling the proximal end portion of thepenile prosthetic with the artificial crus penis formed by theimplantable support. One effect of the method is to provide a trans-malepelvis with a crus penis recess, where the crus penis recess supports animplant in an anatomical position that is the same as, or nearly thesame as, the position of a penis for a natal male.

An embodiment of the method includes locating the neopenis anatomicallyin a natal penis location, one effect of which is to provide thetrans-male with a penis that is appropriately located inferior relativeto the pubic body (not too high up on the pelvis).

An embodiment of the method includes locating at least the proximal endportion of the penile prosthetic in an anatomic position of a proximalend portion of a natal penis, one effect of which is to replicate thelocation of a natal penis having a crus penis.

Embodiments provide a method of implanting a penile implant in aneophallus of a person assigned the female sex at birth. The methodincludes providing an implant bed having an artificial crus penisrecess; implanting the implant bed in the person assigned the female sexat birth, and locating the artificial crus penis recess proximal fromthe neophallus and superior relative to a neourethra formed within theneophallus of the person assigned the female sex at birth; inserting apenile prosthetic into the neophallus; and inserting a proximal endportion of the penile prosthetic into the artificial crus penis recess.One effect of the method is to provide a trans-male with a neophallusimplant that is adapted to accommodate the axial forces associated withpenetrative intercourse.

An embodiment of the method includes attaching a base of the implant bedto bone of a pelvis of the person assigned the female sex at birth andlocating the artificial crus penis recess inferior relative to a pubicbody of the pelvis. One effect of locating the artificial crus penisrecess inferior relative to the pubic body is to ensure that theimplanted penile prosthetic is not “too high up” on the trans-malepelvis, which is an awkward and undesirable location for a penis.

An embodiment of the method includes attaching a base of the implant bedto bone of a pelvis of the person assigned the female sex at birth andlocating the artificial crus penis recess inferior relative to a pubicsymphysis of the pelvis, one effect of which is to ensure a durablefoundation for the implant that supports penetrative intercourse.

An embodiment of the method includes that a proximal end portion of thepenile prosthetic is a conical proximal end portion and the artificialcrus penis recess is a conical recess. The method further includesplacing the conical proximal end portion of the penile prosthetic intothe conical recess of the artificial crus penis recess, one effect ofwhich is to ensure an appropriate location of the implant.

Embodiments provide a method of implanting a penile implant. The methodincludes forming a neophallus and attaching the neophallus to a personassigned the female sex at birth; providing an implant bed having anartificial crus penis recess; implanting the implant bed in the personassigned the female sex at birth; attaching a proximal portion of theimplant bed to a pelvis of the person assigned the female sex at birthand locating the artificial crus penis recess inferior relative to apubic body of the pelvis; and inserting a penile prosthetic into theneophallus and inserting a proximal end portion of the penile prostheticinto the artificial crus penis recess. One effect of the method is toprovide a person assigned the female sex at birth with a penis.

An embodiment of the method includes locating a distal portion of theimplant bed superior relative to a neourethra formed within theneophallus of the person assigned the female sex at birth, one effect ofwhich is to replicate the fundiform ligament of the natal penis of amale.

An embodiment of the method includes locating the artificial crus penisrecess posterior relative to a pubic body of the pelvis, one effect ofwhich is to locate the neophallus implant at an angle in a natal malepelvis location to facilitate penetrative intercourse.

An embodiment of the method includes locating the artificial crus penisrecess proximal from the neophallus, one effect of which is to replicatethe location of a natal male crus penis in the pelvis of a female thatwas born without a crus penis.

Embodiments provide a method of implanting a penile implant in aneophallus of a person assigned the female sex at birth. The methodincludes providing an implant bed having an artificial crus penis recessconnected to a base; implanting the implant bed in the person assignedthe female sex at birth by securing the base of the implant bed to aramus and locating the artificial crus penis recess inferior a pubicbody of the person assigned the female sex at birth; inserting a penileprosthetic into the neophallus; and inserting a proximal end portion ofthe penile prosthetic into the artificial crus penis recess. One effectof the method is to provide a female pelvis with a newly formed penis.

One exemplary method of surgically creating a neopenis includesdissecting tissue away from a vagina to disconnect the vagina fromorgans and connective tissue inside of a pelvis; inverting the vaginaout of the pelvis to provide an inverted vagina by exposing an interiorwall of the vagina outside of the pelvis; inserting a penile prostheticinto the inverted vagina and inside a portion of the pelvis; andsupporting a proximal portion of the penile prosthetic by attaching theproximal portion of the penile prosthetic to the pelvis.

The method can include inserting a bulking material and the penileprosthetic into the inverted vagina.

The method can include removing a cervix by dissecting the cervix awayfrom the vagina.

The method can include removing tissue from a cervix and forming a glanspenis with the tissue removed from the cervix; and attaching the glanspenis to the inverted vagina.

The method can include folding a superior portion of tissue of theinverted vagina and closing the superior portion of tissue of theinverted vagina to a second portion of the inverted vagina thus forminga channel; and placing a portion of a urethra of the trans-male and aportion of a neourethra of the trans-male into the channel.

The method can include inserting a malleable and non-inflatable penileprosthetic into the inverted vagina and inside the portion of thepelvis; and attaching a proximal portion of the malleable andnon-inflatable penile prosthetic to a descending ramus of the pelvis.

The method can include inserting an inflatable penile prosthetic intothe inverted vagina and inside the portion of the pelvis; attaching aproximal portion of the inflatable penile prosthetic to a descendingramus of the pelvis; coupling a reservoir and a pump to the inflatablepenile prosthetic with tubing; and implanting the reservoir and the pumpinto the trans-male.

One embodiment provides a method of implanting a penile implant. Themethod includes providing a neophallus implant having a transfer jointconnected between a distal portion and a first proximal portion, withthe transfer joint having an angle that maintains the distal portion offof a longitudinal axis of the first proximal portion; forming aneophallus; inserting the distal portion into the neophallus and forminga neopenis; and securing the first proximal portion of the neophallusimplant between muscle attached to a ramus of a trans-male pelvis andtissue.

An embodiment of the method includes implanting a pump and a reservoir;coupling the pump and the reservoir to the distal portion of theneophallus implant; and inflating the distal portion of the neophallusimplant to provide the neopenis with an erection.

An embodiment of the method includes forming a tissue pocket alongsideof the ramus and securing the first proximal portion of the neophallusimplant in the tissue pocket between the muscle attached to the ramus ofthe trans-male pelvis and subcutaneous tissue.

One embodiment provides a method of implanting a penile prosthetic in aneophallus. The method includes providing a neophallus implant having atransfer joint connected to an inflatable distal portion, a firstproximal portion, and a second proximal portion such that the neophallusimplant is a Y-shaped inflatable implant; forming a neophallus;inserting the inflatable distal portion into the neophallus; retainingthe first proximal portion of Y-shaped inflatable implant between muscleattached to a first ramus of a trans-male pelvis and first tissuesuperior to the muscle; retaining the second proximal portion ofY-shaped inflatable implant between muscle attached to a second ramus ofthe trans-male pelvis and second tissue superior to the muscle; andengaging a fixed bend in the transfer joint with the at least one of thefirst tissue and the second tissue and constraining movement of theY-shaped inflatable implant.

An embodiment of the method includes forming a first tissue pocketbetween the muscle attached to the first ramus of the trans-male pelvisand the first tissue superior to the muscle; and forming a second tissuepocket between the muscle attached to the second ramus of the trans-malepelvis and the second tissue superior to the muscle.

An embodiment of the method includes maintaining an opening of the firsttissue pocket and maintaining an opening of the second tissue pocket byinserting a place holder into each of the first tissue pocket and thesecond tissue pocket.

An embodiment of the method includes providing the neophallus implantwith a flat first proximal portion and a flat second proximal portion;placing the flat first proximal portion over the muscle attached to thefirst ramus; and placing the flat second proximal portion over themuscle attached to the second ramus.

An embodiment of the method includes forming the fixed bend in thetransfer joint at a pubic arch angle to align the first proximal portionof Y-shaped inflatable implant and the second proximal portion ofY-shaped inflatable implant with a pubic arch of the trans-male pelvis.

One embodiment provides a method of surgically creating a neopenis on atrans-male. The method includes dissecting tissue away from at least anapex of a vagina to disconnect the vagina from organs and connectivetissue inside of a pelvis; inverting the vagina out of the pelvis toprovide an inverted vagina by exposing an interior wall of the vaginaoutside of the pelvis; inserting a penile prosthetic into the invertedvagina and inside a portion of the pelvis; and supporting a proximalportion of the penile prosthetic by securing the proximal portion of thepenile prosthetic to tissue of the pelvis.

An embodiment of the method includes attaching an artificial crus penisrecess to the tissue of the pelvis, and supporting the proximal portionof the penile prosthetic by inserting the proximal portion of the penileprosthetic into the artificial crus penis recess.

An embodiment of the method includes forming a tissue pocket alongsideof each descending ramus of the pelvis, and supporting the proximalportion of the penile prosthetic by inserting the proximal portion ofthe penile prosthetic into the tissue pocket.

An embodiment of the method includes inserting a bulking material andthe penile prosthetic into the inverted vagina.

An embodiment of the method includes removing a cervix by dissecting thecervix away from the vagina.

An embodiment of the method includes removing tissue from a cervix andforming a glans penis with the tissue removed from the cervix; andattaching the glans penis to the inverted vagina.

An embodiment of the method includes forming a glans penis at a distalend of the neopenis with tissue of a cervix.

An embodiment of the method folding an inferior portion of tissue of theinverted vagina and closing the inferior portion of tissue of theinverted vagina to a second portion of the inverted vagina thus forminga channel; and placing one of a portion of a urethra of the trans-maleand a portion of a neourethra of the trans-male into the channel.

An embodiment of the method includes inserting a malleable andnon-inflatable penile prosthetic into the inverted vagina and inside theportion of the pelvis; and attaching a proximal portion of the malleableand non-inflatable penile prosthetic to a descending ramus of thepelvis.

An embodiment of the method includes inserting an inflatable penileprosthetic into the inverted vagina and inside the portion of thepelvis; attaching a proximal portion of the inflatable penile prostheticto a descending ramus of the pelvis; coupling a reservoir and a pump tothe inflatable penile prosthetic with tubing; and implanting thereservoir and the pump into the trans-male.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and are a part ofthis specification. The drawings illustrate embodiments and togetherwith the description explain principles of embodiments. Otherembodiments and advantages of embodiments will be readily appreciated asthey become better understood by reference to the following detaileddescription. The elements of the drawings are not necessarily to scalerelative to each other. Like reference numerals designate correspondingsimilar parts.

FIG. 1A is an illustration of a natal female pelvis, FIG. 1B is anillustration of a natal male pelvis, and FIG. 1C is a cross-sectionalview of a natal male penis.

FIG. 2A is an inferior view of a natal female pelvis and FIG. 2B is aninferior view of a trans-male pelvis including a penile prosthetic andan implantable support.

FIG. 3 is a perspective view of one embodiment of a neophallus implantsystem including a penile prosthetic and an implantable support.

FIG. 4 is a perspective view of one embodiment of an implantablesupport.

FIG. 5 is a front view of the implantable support illustrated in FIG. 4.

FIG. 6 is a perspective view of the implantable support illustrated inFIG. 4 and a plug insertable into the implantable support.

FIG. 7 is a top view of a sheet of material with demarcations useful informing the implantable support illustrated in FIG. 4 .

FIG. 8 is a front inferior view of a natal male pelvis, and FIG. 9 is aperspective view of a trans-male pelvis including the implantablesupport of FIG. 4 attached to the ischiopubic rami.

FIG. 10 is a side view of the trans-male pelvis and the implantedimplantable support illustrated in FIG. 9 .

FIG. 11A is a perspective view of one embodiment of an implantablesupport.

FIG. 11B is a perspective view of the implantable support illustrated inFIG. 11A secured to a trans-male pelvis.

FIG. 12 is a perspective view of one embodiment of an implantablesupport including a base and an artificial crus penis recess connectedto the base.

FIG. 13A is a top view, FIG. 13B is a perspective view, and FIG. 13C isan end view of one embodiment of the artificial crus penis recess of theimplantable support illustrated in FIG. 12 .

FIG. 14 is a perspective view of one embodiment of the artificial cruspenis recess suitable for attachment to the base illustrated in FIG. 12.

FIG. 15 is a top view of the artificial crus penis recess illustrated inFIG. 14 .

FIG. 16 is a schematic view of a proximal connector connected to theartificial crus penis recess illustrated in FIG. 14 .

FIG. 17 is a schematic view of the implantable support illustrated inFIG. 12 is attached to a trans-male pelvis.

FIG. 18 is a front view of one embodiment of an implantable support.

FIG. 19A is a top view of the implantable support illustrated in FIG. 18, and FIG. 19B is a top view of an alternative to the implantablesupport illustrated in FIG. 18 .

FIG. 20A is a schematic view of the implantable support illustrated inFIG. 18 affixed relative to a trans-male pelvis.

FIG. 20B is a schematic view of the alternative implantable supportillustrated in FIG. 19B affixed relative to a trans-male pelvis.

FIG. 21 is a schematic view of one embodiment of an implantable supportoriented relative to a trans-male pelvis.

FIG. 22 is a top view of the implantable support illustrated in FIG. 21.

FIG. 23A is a perspective view of one embodiment of an implantablesupport including a sleeve forming an artificial crus penis recess.

FIG. 23B is a schematic view of the implantable support illustrated inFIG. 23A affixed relative to a pelvis.

FIG. 24A is a perspective view of one embodiment of an implantablesupport including a sleeve provided with ramus straps.

FIG. 24B is a schematic view of the implantable support illustrated inFIG. 24A with the ramus straps affixed to the pelvis.

FIG. 25 is a perspective view of one embodiment of an implantablesupport including a single sleeve integrating a pair of artificial cruspenis recesses.

FIG. 26 is a schematic view of the implantable support illustrated inFIG. 25 oriented relative to a trans-male pelvis.

FIG. 27 is a perspective view of one embodiment of a neophallus implantsystem including a penile prosthetic and an implantable support.

FIG. 28A and FIG. 28B are perspective views of one embodiment of anadapter of the implantable support illustrated in FIG. 27 .

FIG. 29A is a side view, FIG. 29B is a front view, and FIG. 29C is across-sectional view of the implantable support illustrated in FIG. 27 .

FIG. 30 is a schematic view of the implantable support illustrated inFIG. 27 oriented for implantation onto a pelvis.

FIG. 31 is a perspective view of one embodiment of a neophallus implantsystem including a penile prosthetic and an implantable support.

FIG. 32 is a schematic view of one embodiment of an implantable supportlocated relative to a pelvis.

FIG. 33 is a perspective view, FIG. 34 is a side view, and FIG. 35 is atop view of the implantable support illustrated in FIG. 32 .

FIG. 36A is a schematic view of one embodiment of a neophallus implantsystem with a neopenis in a flaccid state, and FIG. 36B is a schematicview of the neophallus implant system with the neopenis in an erectstate.

FIG. 37A-FIG. 37F are schematic views of the neophallus implant systemillustrated in FIG. 36 .

FIG. 38 is a perspective view of one embodiment of a neophallus implantsystem.

FIG. 39A is a schematic view of one embodiment of a neophallus implantsystem with a neopenis in a flaccid state, and FIG. 39B is a schematicview of the neophallus implant system with the neopenis in an erectstate.

FIG. 40 is a perspective view of one embodiment of an implantablesupport relative to a trans-male pelvis.

FIG. 41 is a perspective view of one embodiment of an implantablesupport relative to a trans-male pelvis.

FIG. 42 is a perspective view of one embodiment of an implantablesupport adapted to receive proximal end portions of a penile prostheticduring a phalloplasty procedure.

FIG. 43 is a perspective view of one embodiment of an implantablesupport including a plurality of tissue anchors and an artificial cruspenis recess.

FIG. 44 is a schematic view of one embodiment of a kit of partsincluding a single penile prosthetic implantable in a neophallus of atrans-male pelvis during a female-to-male (FTM) phalloplasty procedure.

FIG. 45 is a schematic view of one embodiment of a kit of partsincluding dual, inflatable penile prosthetics implantable in aneophallus of a trans-male pelvis during a FTM phalloplasty procedure.

FIG. 46 is a schematic view of one embodiment of a kit of parts of aneophallus implant system including dual, malleable penile prostheticsimplantable in a neophallus of a trans-male pelvis during a FTMphalloplasty procedure.

FIG. 47A is a perspective view and FIG. 47B is a cross-sectional view ofone embodiment of an implantable penile prosthetic including anartificial tunica.

FIG. 48 is a perspective view of one embodiment of a neophallus implantsystem.

FIG. 49A is a perspective view of one embodiment of an implantablesupport illustrated alongside the implantable support of FIG. 23 , whichfor comparison is shown in FIG. 49B.

FIG. 50A is a perspective view of one embodiment of an implantablesupport, and FIG. 50B is a cross-sectional view of one-half of theimplantable support.

FIG. 51A is a perspective view of one embodiment of a neophallusimplant.

FIG. 51B is a perspective view of one embodiment of a spine of theneophallus implant of FIG. 51A.

FIG. 51C is a cross-sectional view of the neophallus implant of FIG.51A.

FIG. 52 is a perspective view of one embodiment of a neophallus implantsystem.

FIG. 53 is a perspective view of one embodiment of a kit of partssuitable for customizing an implant during a phalloplasty procedure.

FIG. 54 is a perspective view of one embodiment of a neophallus implantsystem.

FIG. 55 is a cross-sectional view of a penile prosthetic of theneophallus implant system of FIG. 54 .

FIG. 56 is a perspective view of one embodiment of a neophallus implant.

FIG. 57 is a schematic view of the neophallus implant illustrated inFIG. 56 implanted in the pelvis of a trans-male.

FIG. 58 is a perspective view of one embodiment of a neophallus implantincluding bifurcated proximal portions.

FIG. 59A is a schematic view of one embodiment of an implantable placeholder implanted into a trans-male pelvis.

FIG. 59B is a schematic view of the neophallus implant illustrated inFIG. 58 implanted in a space formed by the implantable place holderwithin the pelvis of a trans-male.

FIG. 60A is a perspective view of one embodiment of a transfer jointadapted for use with a neophallus implant having dual penile prostheticdistal portions.

FIG. 60B is one embodiment of a transfer joint adapted for use with aneophallus implant having a single penile prosthetic distal portion.

FIG. 60C is a schematic view of one embodiment of a neophallus implantimplanted in a trans-male pelvis.

FIG. 61 is a partial cross-sectional view of one embodiment of adeflated neophallus implant.

FIG. 62 is a partial cross-sectional view of the neophallus implantillustrated in FIG. 61 after inflation.

FIG. 63 is a partial cross-sectional view of one embodiment of aneophallus implant.

FIG. 64 is a perspective view of the neophallus implant illustrated inFIG. 63 .

FIG. 65 is a partial cross-sectional view of one embodiment of adeflated neophallus implant.

FIG. 66 is a partial cross-sectional view of the neophallus implantillustrated in FIG. 65 after inflation.

DETAILED DESCRIPTION

The drawings illustrate embodiments and together with this writtendescription explain principles and advantages of embodiments.

The features of the various exemplary embodiments described in thisapplication may be combined with each other, unless specifically notedotherwise.

Anterior means situated toward a front of the body.

Cis-male is a person assigned the male sex at birth.

Cis-female is a person assigned the female sex at birth.

Inferior means situated below, closer to the feet than another similarpart of an upright body.

Posterior means situated toward the rear of the body.

Superior means situated toward the head and further away from the feetthan another similar part of an upright body.

Anatomically affirming means one or more anatomical features that alignwith a person's gender identity.

The phrase “situated anatomically in a natal penis position” means aneopenis surgically attached to a trans-male pelvis that is situatedanatomically in the same or similar position as a natal penis of a natalmale pelvis and is suitable for penetrative intercourse.

Gender identity is a person's internal sense of being male, female, orother.

Gender affirming surgery is a surgical procedure to provide a person'sbody with genitalia that aligns with their gender identity.

Glansplasty is a surgical procedure to construct a glans penis on adistal end of a surgically constructed neophallus to provide a patientwith an enlarged glans penis. The glans penis is the sensitive andbulbous structure at the tip of the penis and is anatomically homologousto the clitoral glans.

Metoidioplasty is a word that translates to “a surgical change towardthe male.” Metoidioplasty is generally carried out in two stages,testosterone treatment followed by surgery. During the testosteronetreatment, the clitoris responds by growing longer. During surgery, thesurgeon severs the ligament that holds the clitoris in place under thepubic body, resulting in “clitoral release” that allows the enlargedclitoris to have the appearance of a small penis.

Natal female means a person who is born with all or a substantialportion of female genitalia.

Natal male means a person who is born with all or a substantial portionof male genitalia.

Neopenis means a newly constructed penis, where the neopenis includes aneophallus and a prosthetic inserted into the neophallus.

Neophallus means a newly constructed shaft of skin in the shape of apenis, where the neophallus is formed from tissue donated from a thighor a forearm or other site of that person.

Neoscrotum means a newly formed scrotum, where the newly formed scrotummay be formed from tissue harvested from a donor site or from a localsite such as the labia majora.

Phalloplasty means the surgical construction of the neophallus, andapplies to both cis-male and cis-female. Female-to-Male phalloplasty isthe construction of a penile shaft on a person assigned the female sexat birth to allow their outward genital appearance to conform to theirgender. The surgeon may choose to form the phalloplasty in conjunctionwith metoidioplasty.

Pubic bone means the boney portion of the pelvis that is lateral to thepubic symphysis. The cross-sectional view of FIGS. 1A and 1B show thepubic bone. This boney structure lateral to the pubic symphysis isreferred to in this document as the pubic body.

Scrotoplasty is a surgical procedure in which the labia of the vaginaare surgically stretched and joined through suturing to form aneoscrotum.

Sex is the classification of a person as male or female based upon theappearance of their external anatomy at birth. While sex is classifiedat birth based upon the visual aspect of the genitals, sex is in fact acombination of chromosomes, hormones, internal reproductive organs, andexternal organs.

Transgender means a person whose gender identity differs from the sexthey were assigned at birth.

Trans-male pelvis means a pelvis of a person who was assigned the femalesex at birth that has been surgically modified to receive a neophallusor a neopenis.

Vaginectomy is a surgical procedure to remove all or part of the vagina.

Female-to-Male (FTM) phalloplasty is an extensive surgical procedure.The FTM phalloplasty is typically completed in stages. In one approach,the FTM phalloplasty is completed in three stages, including a firststage to perform the metoidioplasty and form a neophallus; a secondstage including vaginectomy; and a third stage to place a penileprosthetic into the neophallus.

Formation of the neophallus includes a procedure to harvest tissue froma donor site on the patient to form the tubular body of the neophallusand a separate step of harvesting tissue to form a neourethra. In onesuitable approach, a surgeon harvests tissue for the neophallus from theradial forearm in a procedure referred to as a radial forearm free-flapphalloplasty. It is desirable to harvest tissue from a donor sitewithout hair follicles when forming the neourethra as the follicles havethe potential to accumulate deposits from the urine and form a blockage.The interior portion of the radial forearm provides one possiblelocation for the harvesting of tissue suitable for forming theneourethra. The neophallus is surgically attached to a location that issuperior to the location of the natal urethra, since the natal femaleurethra is inferior relative to the bladder and the pubic body. Thesurgeon may choose to begin expanding the labia in a first step of thescrotoplasty. It is desirable to allow the neophallus and the neourethrato heal for a period between 4-6 months before moving to the secondstage of the FTM phalloplasty.

The second stage of the FTM phalloplasty is a time-consuming surgicalprocedure that includes the vaginectomy, which may be combined withlaparoscopic hysterectomy and joining of the natal urethra with theneourethra. After joining the natal urethra with the neourethra thesurgeon will perform glansplasty and any of the remaining steps of thescrotoplasty, for example placing testicular prostheses inside of thenewly formed scrotum. The surgeon may choose to transport the clitoristo the base of the neophallus. It is desirable to allow the second stageto heal for a period between 4-6 months before moving to the third stageof the FTM phalloplasty.

The third stage of the FTM phalloplasty includes placement of a penileprosthetic inside of the neophallus. The penile prosthetic allows theneophallus to achieve an erection. The erect neophallus will not be wellsuited for penetrative intercourse unless the surgeon provides theneophallus with some form of a foundation that will supportcolumn-loading forces.

Some surgeons will attach a portion of an implant for a neopenis to thepubic body, for example with screws, to obtain an amount of foundationalsupport of the neopenis. However, attachment of the neopenis to thepubic body of the trans-male pelvis will not result in a neopenis thatis situated anatomically in a natal penis position. A natal male penishas an external portion and an internal portion called the crus penis.The external portion of the penis accounts for about two-thirds of thepenis length, with the crus penis accounting for the remaining one-thirdof the length. Crus means leg. The crus (crura for plural) penis is theproximal portion of each of the corpus cavernosum of the male penis. Thecrus penis in a male is secured to the pelvis in which each of theproximal crura of the penis diverges away from the midline in theproximal direction and is attached to the ischiopubic ramus. Thediverging and posterior portion of each crus penis is thus inferiorrelative to the pubic body (since each is attached to the descendingischiopubic ramus), such that the natal male penis is in fact attachedwithin the body inferior and posterior to the pubic body (See FIG. 1B).

It is desirable to provide a person who was assigned the female sex atbirth with a neopenis that is situated anatomically in a natal penisposition and that is suitable for penetrative intercourse.

FIG. 1A is an illustration of a female pelvis and FIG. 1B is anillustration of a male pelvis.

The anatomy of the female pelvis locates the bladder posterior of thepubic body, with the urethra descending to a location both posterior andinferior of the pubic body. The anatomy of the male pelvis locates thebladder posterior of the pubic body, with the external penis inferior tothe pubic body and the crus penis both inferior and posterior to thepubic body. The male urethra is longer than the female urethra, andincludes a vertical portion descending from the bladder and a secondportion that extends through the external penis. A proximal portion ofthe penis is suspended by the fundiform ligament of the penis that isconnected between a portion of the pubic body and a base of the penis.

FIG. 1C is a cross-sectional view of a natal male penis. The natal malepenis includes a pair of corpora cavernosa C1 and C2, each surrounded bya tunicae albuginea TA (referred to as a tunica). The tunica TAconstrains the corpus spongiosum CS tissue and contributes to therigidity of the shaft of the penis when erect. Each tunica TA for eachof the corpora cavernosa C1 and C2 meets along a longitudinal plane at aseptum S of the penis. The urethra U is separate from the corporacavernosa C1 and C2. The Buck's fascia Bf surrounds each tunica TA, andthe Darto's fascia surrounds the Buck's fascia. The trans-male does nothave a penis, and the surgically created neophallus lacks the supportingtunica TA structure and the erectile tissue of the corpora cavernosa C1and C2. The embodiments described in this application provide thetrans-male with supporting structure that allows the neopenis of thetrans-male to have an erection that is located in a natal male positionand with sufficient column strength to have penetrative intercourse.

Some FTM phalloplasty procedures locate a penile prosthetic within skinof a neophallus with a proximal portion of the prosthetic attached tothe female pubic body lateral the pubic symphysis. The penile prostheticis connected to the pubic body, for example with bone screws. However,attachment of the penile prosthetic to the pubic body will orient theneophallus parallel to the pubic body lateral of the pubic symphysis,which can potentially result in the neophallus being in an elevatedpositon that is anatomically “too high up,” (see FIG. 1B). Thus,attachment of the penile prosthetic to the pubic body will not providethe trans-male with a neophallus that is situated anatomically in thesame position as a penis of a natal male penis, which is evident whenthe anatomy of the female pelvis (FIG. 1A) is compared to the anatomy ofthe male pelvis (FIG. 1B). Other FTM phalloplasty procedures insert anavailable natal male penile prosthetic into the skin of a neophallus,with a proximal portion of the natal male penile prosthetic secured tothe pubic body lateral of the pubic symphysis. This location of thenatal male penile prosthetic in a trans-male results in the neopenishaving a steep angle and a non-natal location that is elevated too highrelative to the urogenital organs.

FIG. 2A is an inferior view of a female pelvis and FIG. 2B is aninferior view of a trans-male pelvis including a penile prosthetic andan implantable support.

With reference to FIG. 2A, the female pelvis includes the urethralocated between the clitoris and the vagina. The clitoris is the analogto the glans penis and the FTM phalloplasty procedure includesmetoidioplasty using hormones to lengthen the clitoris prior toreleasing the clitoris from its suspensory ligament. During someprocedures, the clitoris is transposed to the base of the neophallus.

The first stage of the FTM phalloplasty procedure also includeslengthening of the urethra concurrent with formation of the neophallus.The lengthened neourethra and the neophallus are both formed with tissueharvested from the radial forearm in a procedure referred to as radialforearm freeflap. In other approaches, the neophallus is formed withtissue harvested from the anterior thigh. The radial forearm freeflapprocedure is the more common approach.

The second stage of the FTM phalloplasty procedure can be combined withlaparoscopic hysterectomy and includes a joining of the lengthenedneourethra to the natal urethra, vaginectomy, glansplasty at the distalneophallus, placement of testicular prosthetics, and transposition ofthe clitoris to the base of the neophallus. In one embodiment of theadvances described in this application, a place saver is implanted intothe neophallus to maintain an opening in the neophallus that is sized tosubsequently receive the penile prosthetic. The place saver is an oblongballoon that is inflated inside of the cavity formed in the neophallus.In one embodiment, a port is provided on an end of the oblong balloon toallow the balloon to be filled with a gas, such as air, or a liquid,such as saline. The oblong balloon includes a groove formed as alongitudinal trough that is sized and adapted to receive the neourethra.

The body is given sufficient time, for example several weeks or months,to heal between both the stage one and stage two procedures.

The third stage of the FTM phalloplasty procedure includes implanting apenile prosthetic inside of the neophallus to provide for an erection ofthe neophallus in the trans-male.

FIG. 2B is an inferior view of the pelvis of a trans-male showing aschematic representation of one penile implant system configured toprovide a person assigned the female sex at birth with a neopenis. Oneembodiment of the penile implant system includes a penile prostheticlocated inside of a neophallus and an implantable support that providesa foundation for the penile prosthetic. The implantable support allowsfor a desired anatomical positioning of the neophallus and provides afoundation that allows for penetrative intercourse.

The implantable support is provided separate from the penile prostheticprior to implantation and includes a base that is attachable to bone ofthe pelvis and an artificial crus penis recess. The artificial cruspenis recess is sized to receive the proximal end of the penileprosthetic.

FIG. 3 is a perspective view of one embodiment of a neophallus implantsystem 20 including a prosthesis 22 and an implantable support 24.

In one embodiment, the prosthesis 22 is an inflatable penile prostheticand includes a penile prosthetic 26, a reservoir 28, and a pump 30connected to the penile prosthetic 26 and the reservoir 28, for exampleby kink resistant tubing 32. In one embodiment, the prosthesis 22 is arigid rod-style of prosthetic that is referred to as an implantablemalleable penile prosthetic. An implanted malleable penile prosthetic ispositioned manually to transition a penis between an erect state and acurved, flaccid state. An implanted malleable penile prosthetic includesa malleable metal core surrounded by a polymer cover, with the malleablemetal core having a column strength adapted to allow penetrativeintercourse with the penile implant.

The penile prosthetic 26 includes a distal end portion 34 thatterminates at a distal end 36 and a proximal end portion 38 thatterminates at a proximal end 40, with a shaft 41 extending between thedistal end portion 34 and the proximal end portion 38. In oneembodiment, the distal end portion 34 includes a glans-shaped bulb 42suitable for providing the neophallus with a glans penis. In oneembodiment, the distal end portion 34 includes a skirt that extends awayfrom the shaft 41 to provide the distal portion of the prosthetic withan umbrella-shape or a mushroom shape that is adapted to prevent theshaft 41 from migrating out of the distal end of the neophallus. Thepenile prosthetic 26 is insertable into a neophallus of a trans-male whowas assigned the female sex at birth. The neophallus of the trans-malelacks a tunica and the corpus cavernosum inside of the tunica. The penisof a natal male includes two corpora cavernosa inside of a tunica pair.An implant for a natal male will include two penile prosthetics, one foreach corpus cavernosum. In contrast, a single inflatable unit issuitable for implantation in the tissue of the neophallus of atrans-male since the neophallus does not have a pair of corporacavernosa to receive a pair of inflatable implants. Suitable materialfor fabricating the penile prosthetic 26 includes silicone,biocompatible polymers such as urethanes, and blends of polymers withurethane, copolymers of urethane, or the like. One suitable penileprosthetic is available from Coloplast Corp., Minneapolis, Minn.

The reservoir 28 is sized to maintain a volume of liquid between about50-300 ml and includes a neck 44 that is smoothly coupled with the kinkresistant tubing 32. In one embodiment, the reservoir 28 is provided asa “cloverleaf” style of reservoir having multiple leaves that may befolded one against the other to compact the reservoir 28 forimplantation into the abdomen of the user, ectopically under the skinand anterior of the rectus sheath, in the space that was formerly thevaginal vault, or in the space of Retzius depending upon the procedureand the preference of the surgeon. One suitable reservoir 28 is sized toretain approximately 130 mL of liquid and is available from ColoplastCorp., Minneapolis, Minn.

The pump 30 includes a pump bulb 46 integrated with the deflation pads48 and operates to move liquid from the reservoir 28 through the tubing32 and into the penile prosthetic 26. The deflation pads 48 operate toopen a flow path to allow the liquid in the penile prosthetic 26 todrain through the tubing 32 back to the reservoir 28. The pump isadapted to be implanted into a neoscrotum, which can be formed bysurgically stretching the labia of the vagina to a size that is suitablefor receiving the pump 30. One suitable pump is available from ColoplastCorp., Minneapolis, Minn. The pump 30 is as described in U.S. Pat.Appln. Pub. 2007/0142700, which issued as U.S. Pat. No. 8,167,788, thedisclosure of which is incorporated by reference in its entirety intothis application.

The reservoir 28, the pump 30, and the tubing 32 are as described inU.S. Pat. Appln. Pub. 2011/0118540, which issued as U.S. Pat. No.8,337,392, the disclosure of which is incorporated by reference in itsentirety into this application.

FIG. 4 is a perspective view and FIG. 5 is a right side view of theimplantable support 24. In one embodiment, the implantable support 24includes an artificial ligament 50 connected between a base 52 and anartificial crus penis recess 54. The base 52 forms an implant bed thatis attachable to the pelvis, and the artificial crus penis recess 54 issized to receive the proximal end portion 38 of the penile prosthetic 26(FIG. 3 ). The artificial ligament 50 is a connecting structure locatedbetween the base 52 and the artificial crus penis recess 54 that isanalogous to the ligament of the penis (FIG. 1 ), which is also referredto as the fundiform suspensory ligament in the natal male. In oneembodiment, the artificial ligament 50 is triangular in shape having ahypotenuse that intersects the base 52, a first leg that intersects withan exterior portion of the artificial crus penis recess 54, and a secondleg that extends from the base 52 to the artificial crus penis recess54. The second leg of the triangular portion of the artificial ligament50 allows the proximal portion of the penile prosthetic to descend adistance away from the pubic body to locate the implanted penileprosthetic anatomically in a location of the male penis in a natal male.The artificial ligament 50 provides the means for supporting animplanted penile prosthetic in a trans-male in an orientation of that ofthe penis of a natal male. The artificial ligament 50, in combinationwith the artificial crus penis recess 54, provide the means foranatomically orienting an implanted penile prosthetic in a trans-male ina position of that of the penis of the natal male. The trans-male pelvisdoes not have a penile ligament (fundiform ligament) or a crus penisrecess. The implantable supports described in this specification (havingone of an artificial ligament or an artificial crus penis recess)provide the means for providing a trans-male with a neopenis having animplanted penile prosthetic, including providing the neopenis with themeans for supporting penetrative intercourse, and the means forsupporting the neopenis for accommodating the axial thrust that isassociated with penetrative intercourse.

In one embodiment, the artificial crus penis recess 54 is conical inshape and tapers from a distal end 58 to a proximal end 60 in a mannerthat is sized to receive the proximal end portion 38 of the penileprosthetic 26. In other embodiments, the artificial crus penis recess 54includes a closed base and is cup-shaped. The artificial crus penisrecess 54 has a recess depth in a range from 0.5-7 cm, and preferablythe recess depth for the artificial crus penis recess is between 1-4 cm.The artificial crus penis recess 54 is adapted to receive the proximalend portion of either an inflatable penile prosthetic or anon-inflatable penile prosthetic (e.g., a malleable prosthetic).

The axis of the artificial crus penis recess 54 is not parallel with thebase 52. In one embodiment, the artificial crus penis recess 54 isoriented at an acute angle A relative to the base 52, which is to saythat the artificial ligament 50 maintains the artificial crus penisrecess 54 at an angle A of between 5-30 degrees relative to the base 52.The angle A advantageously orients the penile prosthetic inserted intothe recess 54 at an angle that approximates the orientation of the malepenis relative to the male pubic body.

FIG. 6 is a perspective view of the implantable support 24 including oneembodiment of an optional plug 64 that is insertable into the artificialcrus penis recess 54. It is desirable to prevent tissue from growinginside of the artificial crus penis recess 54 after the implantablesupport 24 is implanted. As noted above, several weeks may elapse afterthe formation of the neophallus prior to implantation of the penileprosthetic. The plug 64 fills the artificial crus penis recess 54 duringthe healing process and prevents the undesirable ingrowth of tissueinside of the recess 54. The plug 64 extends between a distal end 68 aproximal end 70, each of which is sized to be similar to the size of theopenings formed at the distal end 58 and the proximal end 60,respectively, of the artificial crus penis recess 54. One advantage ofthe plug 64 is that it aids the surgeon in locating the recess 54 whenimplanting the penile prosthetic 26.

FIG. 7 is a top plan view of a sheet 72 of material that is used tointegrally form the ligament 50 located between the base 52 and theartificial crus recess 54. In one embodiment, the sheet 72 of materialis folded and includes a pair of first lines 74 demarcating the junctionof the base 52 and the artificial ligament 50 and a second pair of lines76 demarcating the junction between the artificial ligament 50 and theartificial crus penis recess 54. The sheet 72 is provided as a singlesheet of material that is folded or otherwise formed to provide the base52, the artificial ligament 50, and the artificial crus penis recess 54,the various components of which are held together with mechanical orchemical attachments. In one embodiment, the pair of the first lines 74are folded into alignment and joined, and the second pair of lines 76are folded into alignment and joined. The joints include stitchingplaced through the sheet 72 to form the base 52, the artificial ligament50, and the artificial crus penis recess 54 as illustrated in FIG. 4 .

The sheet 72 is selected from materials such as autograft material (thepatient's own tissue), allograft material (tissue from a cadaver),xenograft material (tissue from another species), or synthetic materialssuch as silicone, polyurethane, reinforced silicone, reinforcedpolyurethane, woven fabrics, meshes, nonwoven fabrics, meshes,fibrillated fibers, or spun and fibrillated fibers that are providedwith voids (pores) configured to allow tissue ingrowth into the sheet72. The pores are generally larger, on average, than 75 μm. In oneembodiment, the implantable support 24 is integrally formed by moldingor 3D printing employing a suitable polymer system.

FIG. 8 is a front inferior view of a male pelvis, and FIGS. 9 and 10 areperspective views of a trans-male pelvis including the implantablesupport 24 and the penile prosthetic 26.

The male pelvis illustrates the shaft of the penis located inferiorrelative to the pubic body and supported by the fundiform ligament ofthe penis. The ischiocavernosus muscle surrounds and supports theproximal portion of the penis to the ischiopubic ramus.

The implantable support 24 provides the trans-male pelvis withrepresentative male anatomy. The male anatomy includes a proximalportion of the penis connected to the ischiopubic ramus, a ligamentconnected between the pubic symphysis and the base of the penis, and anorientation inferior to the pubic body. Embodiments of the neophallusimplant system 20 provides the person who was assigned the female sex atbirth with an analog to the natal male anatomy, where: the base 52 ofthe implantable support 24 is attachable to the ischiopubic ramus tosupport the artificial crus penis recess 54 to allow the recess 54 tosecure the proximal end portion of the penile prosthetic 26 in ananatomically suitable position. Embodiments further provide anartificial ligament 50 that suspends the artificial recess 54 from thebase 52 at an angle to orient the penile prosthetic 26 in a manner thatreplicates the natal male anatomy.

The neophallus implant system 20 is configured to provide a person witha neopenis. The system 20 provides the penile prosthetic 26 having theshaft 41 connected between the distal end portion 34 and the proximalend portion 38. The distal end portion 34 is sized for implantation intothe neophallus of the neopenis. The implantable support 24 is attachableto a descending ramus of a pelvis to provide an artificial crus penis.The proximal end portion 38 of the penile prosthetic 26 is coupled tothe artificial crus penis 54 to locate the neopenis anatomically in anatal penis location.

The neophallus is formed by harvesting tissue from a donor site on thepatient to form the tubular body of the neophallus. A neourethra isformed by harvesting tissue to form a neourethra. In one suitableapproach, a surgeon harvests tissue for the neophallus from the radialforearm. It is desirable to harvest tissue from a donor site withouthair follicles when forming the neourethra as the follicles have thepotential to accumulate deposits from the urine and form a blockage. Theinterior portion of the radial forearm provides one possible locationfor the harvesting of tissue suitable for forming the neourethra. Theneophallus is surgically attached to a location that is superior to thelocation of the natal urethra, since the natal female urethra isinferior relative to the bladder and the pubic body. The surgeon maychoose to begin expanding the labia in a first step of the scrotoplasty.It is desirable to allow the neophallus and the neourethra to heal for aperiod between 4-6 months before moving to the second stage of the FTMphalloplasty.

A vaginectomy is completed, which may be combined with laparoscopichysterectomy and joining of the natal urethra with the neourethra. Afterjoining the natal urethra with the neourethra the surgeon will performglansplasty and any of the remaining steps of the scrotoplasty, forexample placing testicular prostheses inside of the newly formedscrotum. The surgeon may choose to transport the clitoris to the base ofthe neophallus. It is desirable to allow the second stage to heal for aperiod between 4-6 months before moving to the third stage of the FTMphalloplasty.

The penile prosthetic 26 is implanted inside of the neophallus. Thepenile prosthetic 26 of the system 20 allows the neophallus to achievean erection. The erect neophallus will not be well suited forpenetrative intercourse unless the surgeon provides the neophallus withsome form of a foundation that will support column-loading forces. Theimplantable support 24, having the artificial ligament 50 connectedbetween the base 52 and the artificial crus penis recess 54, providesthe neophallus with a foundation that will support column-loadingforces. The implantable support 24 is formed and attached to the ramusas described above. The proximal end portion of the penile prosthetic 26is inserted into the artificial crus penis recess 54 and the penileprosthetic 26 is connected to the reservoir 28 by the tubing 32 and isconnected to the pump 30 by the tubing 32 (see FIG. 3 ). The artificialligament 50 provides support to the prosthetic 26 and orients theimplant in an orientation that mimics the natal male anatomy. Thereservoir 28 and the pump 26 are implanted in the abdomen (or evensubcutaneously) and the neoscrotum, respectively, and the incisions areclosed. The trans-male is thus provided with a neopenis that is situatedanatomically in a natal penis position and suited for penetrativeintercourse.

FIG. 11A is a perspective view of one embodiment of an implantablesupport 84 and FIG. 11B is a perspective view of the implantable support84 secured to the pelvis. In one embodiment, the implantable support 84includes a pair of artificial ligaments 90 a, 90 b connected between abase 92 and a respective pair of artificial crus penis recesses 94 a, 94b. The base 92 forms an implant bed that is attachable to the pelvis andeach of the artificial crus penis recesses 94 a, 94 b is sized toreceive a proximal end portion of a dual cylinder penile prosthetic. Oneexample of a dual cylinder penile prosthetic is an inflatable dualcylinder system available from Coloplast Corp., Minneapolis, Minn. andidentified as the TITAN® brand inflatable penile prosthesis. Anotherexample of a dual cylinder penile prosthetic is a malleable dualcylinder system available from Coloplast Corp., Minneapolis, Minn. andidentified as the GENESIS brand penile prosthesis. The artificialligaments 90 a, 90 b are a connecting structure located between the base92 and the artificial crus penis recesses 94 a, 94 b and are analogousto the fundiform suspensory ligament present in the natal male betweenthe pubic body and the penis.

In one embodiment, the artificial crus penis recesses 94 a, 94 b areconical in shape and tapers from a distal end to a proximal end in amanner that is sized to receive the proximal end portion of eachcylinder of the penile prosthetic. In other embodiments, the artificialcrus penis recesses 94 a, 94 b have a closed base and are cup-shaped.The artificial crus penis recesses 94 a, 94 b have a recess depth in arange from 0.5-7 cm, and preferably the recess depth for each of theartificial crus penis recess is between 1-4 cm.

The artificial crus penis recesses 94 a, 94 b are not parallel with thebase 92. In one embodiment, the axes of the artificial crus penisrecesses 94 a, 94 b are oriented at an acute angle A relative to thebase 92, which is to say that the artificial ligaments 90 a, 90 bmaintain each of the artificial crus penis recesses 94 a, 94 b at anangle A of between 5-30 degrees relative to the base 92. The angle Aadvantageously orients the penile prosthetic inserted into the recesses94 a, 94 b at an angle that approximates the orientation of the malepenis relative to the male pubic body.

In one embodiment, an optional plug is insertable into each of theartificial crus penis recesses 94 a, 94 b to prevent tissue fromencapsulating into the recesses.

FIG. 12 is a perspective view of one embodiment of an implantablesupport 100. The implantable support 100 includes a base 102 that isattachable to a pelvis of a person assigned the female sex at birth, andan artificial crus penis recess 104 connected to the base 102. The base102 provides an implant bed that supports the artificial crus penisrecess 104 to allow a person who was assigned the female sex at birth tohave a neopenis that is situated anatomically in the same position as anatal penis.

In one embodiment, the base 102 is fabricated from human or animaltissue or a synthetic material. Suitable tissue includes autograftmaterial (the patient's own tissue), allograft material (tissue from acadaver), or xenograft material (tissue from another species). Suitablesynthetic materials include fabrics, textiles, or meshes formed from apolymer material. Examples of suitable synthetic materials includesilicone, polyurethane, reinforced silicone, reinforced polyurethane,woven fabrics, meshes, nonwoven fabrics, meshes, fibrillated fibers, orspun and fibrillated fibers that are provided with voids (pores)configured to allow tissue ingrowth into the base 102. In oneembodiment, the base 102 is fabricated from a mesh knitted from apolypropylene monofilament fiber, where the knitted mesh has a system ofpores or holes or openings selected to allow tissue to grow through themesh. The pores are generally larger, on average, than 75 μm.

In one embodiment, the base 102 extends between longitudinal edges 106,108 and the lateral edges 110, 112. In one embodiment, a section of thebase 102 between the lateral edge 110 and the artificial crus penisrecess 104 forms an artificial ligament 114. The artificial ligament 114is adapted to suspend and support the artificial crus penis recess 104when the implantable support 100 is secured to the pelvis, and thus actsto provide the person assigned the female sex at birth with an analog tothe fundiform ligament that is present in a natal male. The artificialligament 114 provides the means for supporting an implanted penileprosthetic in a trans-male in an orientation of that of the penis of anatal male. The artificial ligament 114, in combination with theartificial crus penis recess 104, provide the means for anatomicallyorienting an implanted penile prosthetic in a trans-male in a positionof that of the penis of the natal male. The trans-male pelvis does nothave a penile ligament (fundiform ligament) or a crus penis recess. Theimplantable supports described in this specification (having one of anartificial ligament or an artificial crus penis recess) provide themeans for providing a trans-male with a neopenis having an implantedpenile prosthetic, including providing the neopenis with the means forsupporting penetrative intercourse, and the means for supporting theneopenis for accommodating the axial thrust that is associated withpenetrative intercourse.

FIG. 13A is a top view, FIG. 13B is a perspective view, and FIG. 13C isan end view of the artificial crus penis recess 104. Regarding FIG. 12and FIG. 13 , the artificial crus penis recess 104 includes a distalbase 116 that is attachable to the base 102, a proximal base 118, and abody 119 extending between the distal base 116 and the proximal base118. In one embodiment, the proximal base 118 includes a suture port 120that allows the surgeon to secure the proximal base 118 to the internalstructure of the pelvis. For example, in one embodiment the suture port120 is configured to receive a length of suture to allow the surgeon tosecure the proximal base 118 to tissue within the pelvis, such as aligament at the floor of the pelvis. In one embodiment, the distal base116 includes a first portion 122 that is attachable to a second portion124 of the artificial crus penis recess 104. The base 102 is capturedbetween the first portion 122 and the second portion 124 to secure thebase 102 relative to the artificial recess 104. For example, the firstportion 122 is attachable to the second portion 124 by a friction fit,or a snap fit, or other form of closure with the base 102 locatedbetween the first portion 122 and the second portion 124. In oneembodiment, the body 119 is tapered to converge from the distal base 116to the proximal base 118. In one embodiment, the body 119 provides atapered conical interior recess that is sized to receive a proximal endportion of a penile prosthetic.

Suitable materials for forming the artificial crus penis recess 104include metal and plastic. One suitable metal includes stainless steel.Suitable plastics include polypropylene, polyethylene, silicone, orpolysulfone. One example of the support 100 includes a polypropylenebase 102 and a polypropylene artificial crus penis recess 104.

FIG. 14 is a perspective view, FIG. 15 is a top view, and FIG. 16 is anexpanded top view of one embodiment of an artificial crus penis recess134.

In one embodiment, the artificial crus penis recess 134 includes adistal base 136, a proximal base 138, and a body 139 extending betweenthe distal base 136 and the proximal base 138.

In one embodiment, the distal base 136 includes openings 140 that areconfigured to allow the distal base 136 to be attached to a support basewith a mechanical coupling, such as the support base 102 (FIG. 12 ). Thedistal base 136 is illustrated as a rectangle, although other shapes ofthe perimeter are also acceptable, such as a circle shape, andoval-shaped, or a square shape.

In one embodiment, the proximal base 138 includes an anchor pad 142 thatis configured to allow the surgeon to secure the proximal base 138 totissue internal to the pelvis. In one embodiment, the anchor pad 142 isfabricated to include an orifice 144 with a smooth entrance 146 and asmooth exit 148. The orifice 144 is configured to receive a length ofsuture or other attachment material selected by the surgeon in suitablefor anchoring to a ligament or other soft tissue inside of the pelvis.

FIG. 17 is a schematic view of a pelvis of a trans-male including theimplantable support 100 secured to the pelvis. During the FTMphalloplasty procedure the vagina and other tissues are removed from thepelvis. The ischiocavernosus muscle remains attached to the ischiopubicramus. The longitudinal edge 106 of the base 102 is secured to tissue ofthe right obturator foramen, the longitudinal edge 108 is secured totissue of the left obturator foramen, and the artificial ligament 114supports the artificial crus penis recess 104 inferior relative to thepubic body. Implantation of the implantable support 100 is less invasivethan drilling into the pubic body, as is sometimes employed whensecuring a prosthesis to the pelvis of a trans-male. The implantablesupport 100 provides an anatomically appropriate support to thetrans-male that allows placement of the penile prosthetic under or lowerrelative to the pubic body as compared to those prosthetics that arescrewed into the pelvic bone. The artificial ligament 114 provides anatural suspension structure superior (above) the artificial crus penisrecess 104, which provides added support allowing penetrativeintercourse with the implanted prosthetic.

FIG. 18 is a front view of one embodiment of an implantable support 150.The implantable support 150 is implantable into the pelvis of atrans-male to provide an implant bed that supports a penile prostheticof a neopenis in a natal male orientation and to allow penetrativeintercourse with the neopenis.

In one embodiment, the implantable support 150 includes a base 152 thatis attachable to the descending pubic rami of the pelvis, and artificialcrus penis recess 154 formed as a channel in the implantable support150, and an artificial crus ligament 156 superior relative to theartificial crus penis recess 154. The artificial ligament 156 providesthe means for supporting an implanted penile prosthetic in a trans-malein an orientation of that of the penis of a natal male. The artificialligament 156, in combination with the artificial crus penis recess 154,provide the means for anatomically orienting an implanted penileprosthetic in a trans-male in a position of that of the penis of thenatal male. The trans-male pelvis does not have a penile ligament(fundiform ligament) or a crus penis recess. The implantable supportsdescribed in this specification (having one of an artificial ligament oran artificial crus penis recess) provide the means for providing atrans-male with a neopenis having an implanted penile prosthetic,including providing the neopenis with the means for supportingpenetrative intercourse, and the means for supporting the neopenis foraccommodating the axial thrust that is associated with penetrativeintercourse.

In one embodiment, the base 152 and the artificial crus ligament 156combine to form a bridge having an increased surface area at each sideof the base 152. The increased surface areas of the base 152 are encasedin bone putty. The bone putty is adapted to secure the base 152 to eachof the descending rami to facilitate growing the base 152 into the rami.The bone putty is placed on the sides 152 of the support 150 and isselected to recruit osteoprogenitor cells to generate new bone growth. Asuitable bone putty is formed from demineralized bone matrix processedfrom human bone and mixed with sodium hyaluronate. Another suitable boneputty is a NOVABONE® bioactive synthetic bone graft identified availablefrom NovaBone, Jacksonville, Fla. In one approach, the bones of the ramiare treated with a bone growth promoter that encourages osteogenesis andhas a synergistic effect when in contact with the bone putty. The boneputty secures the support 150 to the bones of the rami by encouragingnew bone growth around a portion of the support. The connecting bridgebetween the sides 152 includes the artificial crus penis recess 154,which is provided as a socket to retain a portion of the implantedprosthetic. One procedure includes lengthening of the urethra concurrentwith formation of the neophallus during a first surgical procedure. Thelengthened neourethra is formed with tissue harvested from the radialforearm, and the neophallus is formed with tissue harvested from theanterior thigh. A second surgery of the FTM phalloplasty procedurefurthers the process by joining the lengthened neourethra to the natalurethra, followed by a vaginectomy, glansplasty at the distalneophallus, placement of testicular prosthetics, possible transpositionof the clitoris to the base of the neophallus, and implantation of thesupport bonded to the rami with the bone putty. The body is given timeto heal prior to implanting a penile prosthetic inside of theneophallus.

FIG. 19A is a top view of the implantable support 150. The base 152forms a jaw that is sized to engage with the descending pubic ramus oneach side of the pelvis. The base 152 or the jaw 152 includes a firstclamping segment 158 connected to and spaced apart from a secondclamping segment 160. The first clamping segment 158 is sized forattachment to an anterior surface of the descending pubic ramus and thesecond clamping segment 160 is sized for attachment to a posteriorsurface of the descending pubic ramus. During implantation, the surgeonwill suitably dissect tissue away from the pelvis and affix the base 152to the descending ramus with a tool that bends the jaw 152 intoengagement with the bone of the ramus. In one embodiment, each of thefirst clamping segment 158 and the second clamping segment 160 includesan engagement tooth 162 that is adapted to penetrate and engage with thebone of the ramus.

The artificial crus penis recess 154 is formed as a channel through athickness of the implantable support 150. In one embodiment, theproximal end portion of the penile prosthetic is conical, orfrusto-conical, and the channel of the recess 154 is likewise conicaland sized to accept the proximal end portion of the penile prosthetic.

FIG. 19B is an alternative embodiment to the implantable support 150 ofFIG. 19A and includes an adjustable base 152′ movably coupled to eachend portion of a brace 164 of the implantable support by a sliding ring165. A suitable artificial crus penis recess 154′ is formed as a channelthrough a thickness of the brace 164 implantable support 150, where thethrough channel of the recess 154′ supports the proximal end portion ofthe penile prosthetic. An artificial ligament is provided by thatportion of the brace 164 that is superior to the artificial crus penisrecess 154′. The location of attachment of the first adjustable base152′ on the patient's right side may not be at the same location alongthe descending ramus as a location of a second adjustable base 152′ onthe patient's left side. The sliding ring 165 allows the position of theadjustable base 152′ to be move to a desired location before the surgeonsecures the jaw 152′ to the descending ramus. Engagement teeth 162′ areprovided on each of the adjustable bases 152′ to ensure positiveengagement between the base 152′ and the ramus, even if the location ofeach of the bases 152′ is not symmetric left-to-right on the patient.The artificial ligament 156′ provides the means for supporting animplanted penile prosthetic in a trans-male in an orientation of that ofthe penis of a natal male. The artificial ligament 156′, in combinationwith the artificial crus penis recess 154′, provide the means foranatomically orienting an implanted penile prosthetic in a trans-male ina position of that of the penis of the natal male. The trans-male pelvisdoes not have a penile ligament (fundiform ligament) or a crus penisrecess. The implantable supports described in this specification (havingone of an artificial ligament or an artificial crus penis recess)provide the means for providing a trans-male with a neopenis having animplanted penile prosthetic, including providing the neopenis with themeans for supporting penetrative intercourse, and the means forsupporting the neopenis for accommodating the axial thrust that isassociated with penetrative intercourse.

FIG. 20A is a schematic view of the implantable support 150 secured to apelvis of a trans-male. A suitable vaginectomy or other dissection hasprepared the tissue between the descending pubic rami to receive theimplantable support 150. The base 152 is clamped into engagement witheach of the respective descending pubic rami. The artificial crus penisrecess 154 is located on the midline of the pelvis. The proximal endportion of the penile prosthetic is insertable into the recess 154 tolocate the penile prosthetic anatomically in a natal penis position andthat is suitable for penetrative intercourse. The artificial ligament156 provides support to the penile prosthetic in in the area superiorrelative the recess 154, and is the analog to the fundiform ligament ofthe natal male.

FIG. 20B is a schematic view of the implantable support of FIG. 19Bsecured to a pelvis of a trans-male. One of the adjustable bases 152′ isclamped into engagement with a ramus on the patient's right side and thesecond of the adjustable bases 152′ is clamped into engagement with aramus on the patient's left side. In this case, the right sideadjustable base 152′ is cephalad relative to the left side adjustablebase. The artificial crus penis recess 154′ is located near the midlineof the pelvis and positioned to receive the proximal end portion of thepenile prosthetic. The artificial ligament 156′ provides support to thepenile prosthetic in in the area superior relative the recess 154′, andis the analog to the fundiform ligament of the natal male.

The implantable support 150 and its alternative (FIG. 19B) provide botha person assigned the female sex at birth and a natal male with aneopenis that is situated anatomically in an appropriate natal penisposition and that is suitable for penetrative intercourse.

FIG. 21 is a schematic view of one embodiment of an implantable support170 oriented relative to a schematic diagram of a pelvis of atrans-male, and FIG. 22 is a top view of the implantable support 170.

The implantable support 170 includes a base 172, an artificial cruspenis 174, and an artificial ligament 176. The base 172 includes a firstleg 176 connected to a second leg 178 by a bridge 180. The first leg 176and the second leg 178 have a longitudinal length that is greater than avertical length (or height) of the bridge 180. The increasedlongitudinal length of the legs 176, 178 adapts the implantable supportto have an increased surface area in a location that is attachable tothe pelvis. In one embodiment, the implantable support provides animplant bed and the legs 176, 178 in combination with the bridge 180provides a frontal area that resembles a “dog bone.” The first leg 176is attachable to a descending ramus on the right-hand side of thepatient, and the second leg 178 is attachable to a descending ramus onthe left-hand side of the patient. Suitable attachment mechanismsinclude bone screws, clamps, adhesive coupling and a mesh-interface todrive tissue growth around the base 172. The bridge 180 spans betweenthe legs 176, 178 to provide a supporting structure for the implantablesupport 170. The artificial ligament 176 provides the means forsupporting an implanted penile prosthetic in a trans-male in anorientation of that of the penis of a natal male. The artificialligament 176, in combination with the artificial crus penis recess 174,provide the means for anatomically orienting an implanted penileprosthetic in a trans-male in a position of that of the penis of thenatal male. The trans-male pelvis does not have a penile ligament(fundiform ligament) or a crus penis recess. The implantable supportsdescribed in this specification (having one of an artificial ligament oran artificial crus penis recess) provide the means for providing atrans-male with a neopenis having an implanted penile prosthetic,including providing the neopenis with the means for supportingpenetrative intercourse, and the means for supporting the neopenis foraccommodating the axial thrust that is associated with penetrativeintercourse.

In one embodiment, the increased surface areas of the base 172 areencased in bone putty that is adapted to secure the base 172 to each ofthe descending rami to facilitate growing the base 172 into the rami.The bone putty is placed on the sides 172 of the support 170 and isselected to recruit osteoprogenitor cells to generate new bone growth.One suitable bone putty is formed from demineralized bone matrixprocessed from human bone and mixed with sodium hyaluronate. Anothersuitable bone putty is a NOVABONE® bioactive synthetic bone graftidentified available from NovaBone, Jacksonville, Fla. In one approach,the bones of the rami are treated with a bone growth promoter thatencourages osteogenesis and has a synergistic effect when in contactwith the bone putty. The bone putty secures the support 170 to the bonesof the rami by encouraging new bone growth around a portion of thesupport.

The artificial crus penis recess 174 is formed as a channel through athickness of the implantable support 170. In one embodiment, theproximal end portion of the penile prosthetic is conical, orfrusto-conical, and the channel of the recess 174 is likewise conicaland sized to accept the proximal end portion of the penile prosthetic.When the penile prosthetic is secured within the artificial crus penisrecess 174, the implantable support 170 provides a backboard or animplant bed that allows penetrative intercourse with the penileprosthetic.

FIG. 23A is a perspective view of one embodiment of an implantablesupport 200, and FIG. 23B is a schematic view of the implantable support200 secured to a pelvis of a trans-male.

The implantable support 200 includes a base 202, in artificial cruspenis recess 204, and an artificial ligament 206 connected between thebase 202 and the artificial crus penis recess 204. The artificial cruspenis recess 204 is sized to receive a penile implant. The implantablesupport 200, as illustrated, does not contain a penile implant, but issized to receive a penile implant in a subsequent step of thephalloplasty procedure.

In one embodiment, the base 202 provides a proximal end portion of theimplantable support 200 and is adapted to be attached around a portionof a descending pubic ramus of the pelvis. In one embodiment, the base202 is provided as a flap that has a first section 208 and an opposingsecond section 210. The base 202 is fabricated from a flexible materialsuch as a fabric or a mesh and is analogous to ligaments that anchor apenis to the bony pelvis in a natal male.

The artificial crus penis recess 204 is a recess that is formed insideof the sleeve 212, where the sleeve 212 includes an opening 214. In oneembodiment, the sleeve 212 approximates the shape of the tunica thatsurrounds the cavernous body of the corpora cavernosa of a natal male.The sleeve 212 extends from a proximal end portion 216 to a distal endportion 218. The proximal end portion 216 is secured to the base 202 bythe artificial ligament 206. In one embodiment, the distal end portion218 of the sleeve 212 includes a padded construction that is adapted toreduce or distribute pressure applied inside of the sleeve 212 by apenile prosthetic that is inserted into the sleeve 212, for exampleduring penetrative intercourse. In one embodiment, the proximal endportion 216 also includes a padded construction to distribute the stressof the penile prosthetic pressing against the sleeve 212. Suitablepadded construction includes silicone, a silicone pouch, a gel, a gelfilled pouch integrated with the implantable support 200, orcombinations of these. The sleeve 212 is an artificial tunica 212 for aneopenis implanted in a trans-male. The trans-male pelvis, andspecifically the neophallus created for the trans-male pelvis, does nothave a tunica. Conventional penile implants implanted into a neophallusof a trans-male have the possibility of undesirably eroding the tissueof the neophallus and poking through the skin (referred to as extrusion,or erosion). The artificial tunica provides the means for reducingerosion of an implanted penile prosthetic through the neophallus of aneopenis implanted in a trans-male. The artificial tunica provides themeans for supporting the implanted penile prosthetic within theneophallus of the trans-male. The artificial tunica provides the meansfor reducing or preventing the movement of the implanted penileprosthetic within the neophallus off of the longitudinal axis of theneophallus.

The artificial ligament 206 provides the means for supporting animplanted penile prosthetic in a trans-male in an orientation of that ofthe penis of a natal male. The artificial ligament 206, in combinationwith the artificial crus penis recess 204, provide the means foranatomically orienting an implanted penile prosthetic in a trans-male ina position of that of the penis of the natal male. The trans-male pelvisdoes not have a penile ligament (fundiform ligament) or a crus penisrecess. The implantable supports described in this specification (havingone of an artificial ligament or an artificial crus penis recess)provide the means for providing a trans-male with a neopenis having animplanted penile prosthetic, including providing the neopenis with themeans for supporting penetrative intercourse, and the means forsupporting the neopenis for accommodating the axial thrust that isassociated with penetrative intercourse.

The opening 214 is sized to receive the shaft of the penile prosthetic.In one embodiment, the surgeon is instructed to close the opening 214after insertion of the penile prosthetic.

The sleeve 212 is suitably fabricated from a textile material, a meshmaterial, or a fabric such as a polyester fabric or a reasonable andwaterproof fabric formed from a fibrillated fiber ofpolytetrafluoroethylene.

FIG. 23B is a schematic view of the implantable support 200 attached toa pelvis of a trans-male. The first section 208 and the second section210 of the base 202 are wrapped around a portion of the descending pubicramus of the pelvis and secured, for example with a series of suturestitches. A penile prosthetic, for example a penile prosthetic asillustrated in FIG. 3 is inserted into the artificial crus penis recess204 through the opening 214. The penile prosthetic extends along alength of the sleeve 212. The penile prosthetic and the sleeve 212 aresupported by the artificial ligament 206, which is formed by a junctionof the base 202 and the sleeve 212.

FIG. 24A is a perspective view of one embodiment of an implantablesupport 200′ including a sleeve 212′ provided with ramus straps 208′ and210′.

The support 200′ is like the support described above but additionallyincludes ramus straps 208′ and 210′ that are sized and located to fixatethe sleeve 212′ to the ramus by wrapping around the ramus and attachingback to the sleeve 212′ or to the strap. The ramus strap 208′ is apaired strap with each strap of the paired strap 208′ adapted tosurround the ramus and connect with its mate. The ramus strap 210′ is asingle strap sized for placement around the ramus and over the sleeve212′. Suitable material for forming the straps 208′ and 210′ includewoven fabrics, nonwoven fabrics, meshes, knitted fabrics, or films. Inone embodiment, the straps 208′ and 210′ are formed from a knittedpolypropylene mesh having a basis weight in a range from 50-200 g/m².

FIG. 24B is a schematic view of the implantable support 200′ with theramus strap 208′ secured to an inferior portion of the descending pubicramus and the ramus strap 210′ secured to a superior portion of thedescending pubic ramus. A similar support is attached to thecontralateral descending pubic ramus. The supports 200′ secure andretain a penile prosthetic, and the support 200′ and the prosthetic areimplanted into a neophallus. Embodiments of the support 200′ locate theneopenis anatomically in the same position as a natal penis suitable forpenetrative intercourse.

FIG. 25 is a perspective view of one embodiment of an implantablesupport 220 and FIG. 26 is a schematic view of the implantable support220 relative to a pelvis of a trans-male.

In one embodiment, the implantable support 220 includes a base 222, afirst artificial crus penis recess 224 a and a second artificial cruspenis recess 224 b, and an artificial ligament 226. Some penileprosthetics are provided in a dual cylinder format, and the implantablesupport 220 provides a first sleeve 232 a sized to receive one of theimplantable cylinders and a second sleeve 232 b sized to receive asecond of the implantable cylinders of the penile prosthetic. Each ofthe first sleeve 232 a and the second sleeve 232 b provides an analog tothe to the tunica surrounds each corpora cavernosum in the natal malepenis. In one embodiment, the first sleeve 232 a is joined to the secondsleeve 232 b by a midline junction that integrates the sleeves into oneunit. In one embodiment, a proximal end portion 236 of the sleeves istapered to receive a proximal end portion of the penile prosthetic, anda distal end portion 238 of each of the sleeves is tapered to receivethe distal end portion of the penile prosthetic. In one embodiment, thedistal end portion 238 of the sleeves is fabricated to provide a bulbousarea that is an analog to the glans penis. In one embodiment, theimplantable support 220 provides a coupled pair of artificial tunica 224a, 224 b. The artificial tunica provides the means for reducing erosionof an implanted penile prosthetic through the neophallus of a neopenisimplanted in a trans-male. The artificial tunica provides the means forsupporting the implanted penile prosthetic within the neophallus of thetrans-male. The artificial tunica provides the means for reducing orpreventing the movement of the implanted penile prosthetic within theneophallus off of the longitudinal axis of the neophallus.

The artificial ligament 226 provides the means for supporting animplanted penile prosthetic in a trans-male in an orientation of that ofthe penis of a natal male. The artificial ligament 226, in combinationwith the artificial crus penis recesses 224 a, 224 b, provide the meansfor anatomically orienting an implanted penile prosthetic in atrans-male in a position of that of the penis of the natal male. Thetrans-male pelvis does not have a penile ligament (fundiform ligament)or a crus penis recess. The implantable supports described in thisspecification (having one of an artificial ligament or an artificialcrus penis recess) provide the means for providing a trans-male with aneopenis having an implanted penile prosthetic, including providing theneopenis with the means for supporting penetrative intercourse, and themeans for supporting the neopenis for accommodating the axial thrustthat is associated with penetrative intercourse.

FIG. 26 is a schematic view of a trans-male pelvis and the implantablesupport 220. The base 222 is sized to be affixed and bridge across fromthe left descending pubic ramus to the right descending pubic ramus. Aproximal flap portion of the base 222 is provided for attachment to theperineal body. The artificial ligament 226 supports and orients each ofthe tunica sleeves 232 a, 232 b in an anatomically natal male positionrelative to the pelvis.

FIG. 27 is a perspective view of one embodiment of a neophallus implantsystem 250 including a penile prosthetic 252 and an implantable support254, where the implantable support 254 includes an artificial crus penisrecess 256 and an adapter 258. The adapter 258 is configured to securethe penile prosthetic 252 to the artificial crus penis recess 256.During implantation, the implantable support 254 is secured to a portionof the ramus and to a portion of the pubic body, such as the pubicsymphysis, to support the penile prosthetic 252 implanted into aneopenis. The neophallus implant system 250 allows the neopenis to besituated anatomically in the same position as a natal penis suitable forpenetrative intercourse.

A neophallus of a neopenis in a trans-male does not have a pair oftunica each surrounding a corpora cavernosum, as would be present in anatal penis. Some penile prosthetics implanted in men to treat erectiledysfunction have two prosthetic tubes, or cylinders, each of which isimplanted into one of the dilated corpora cavernosa. Some surgeonsdesire to employ such a two-cylinder prosthetic during FTM phalloplasty,and the neophallus implant system 250 is adapted to provide anartificial crus penis recess 256 for each of the cylinders of thetwo-cylinder prosthetic.

The penile prosthetic 252 includes cylinders 262 for implantation into aneophallus, a reservoir 264, and a pump 266 connected to the cylinders262 and the reservoir 264, for example by kink resistant tubing 268.

Each of the cylinders 262 includes a shaft 271 extending between aproximal end 270 and a distal end 272 of the cylinder 262. The cylinders262 are fabricated from material configured to collapse when thecylinders 262 are deflated to provide the neopenis with a flaccid stateand expand when the cylinders 262 are inflated with liquid to providethe neopenis with an erection. Suitable material for fabricating thecylinders 262 includes silicone, biocompatible polymers such asurethanes, and blends of polymers with urethane, copolymers of urethane,or the like. One suitable inflatable prosthetic useful with the implantsystem 250 is the TITAN® inflatable penile prosthetic available fromColoplast Corp., Minneapolis, Minn.

The reservoir 264 is sized to maintain a volume of liquid between about50-300 ml and includes a neck 274 that is smoothly coupled with the kinkresistant tubing 268. In one embodiment, the reservoir 264 is providedas a “cloverleaf” style of reservoir having multiple flanges that may befolded one against the other to compact the reservoir 264 forimplantation into the abdomen of the user. One suitable reservoir 264 issized to retain approximately 130 mL of liquid and is available fromColoplast Corp., Minneapolis, Minn.

The artificial crus penis recess 256 is adapted to accommodate aninflatable penile prosthetic, such as the penile prosthetic 252, or amalleable and non-inflatable penile prosthetic. The malleable penileprosthetic provides a pair of rods that are adapted to be formed/bent bythe user into a desired configuration (erect or non-erect, as examples).The malleable prosthetic is not inflatable, and instead forms anerection by column strength provided by a silver wire rod enclosed in aflexible polymer sheath. One suitable malleable penile prosthetic usefulwith the implant system 250 is the GENESIS malleable penile prosthesisavailable from Coloplast Corp., Minneapolis, Minn.

FIG. 28A and FIG. 28B are perspective views of the adapter 258. Theadapter 258 is as described in U.S. Pat. Appln. Pub. 2010/0121137, whichissued as U.S. Pat. No. 7,976,457, the disclosure of which isincorporated by reference in its entirety into this application. Theadapter 258 has a proximal end 280 opposite of a distal end 282, whereeach of the ends 280, 282 include an opening 281, 283, respectively. Theadapter 258 includes a side surface 284 extending between the ends 280,282. A series of slots 286 is formed in the side surface 284 to providethe adapter 258 with the fingers 288. A lip 290 is provided at theproximal end 280 of the adapter 258. The combination of the fingers 288and the lip 290 allow the adapter 258 to flex open to receive theproximal end 270 of the cylinder 262 of the penile prosthetic. The lip290 is configured to bite down upon the proximal end portion of thecylinder 262 to prevent sliding of the cylinder relative to theartificial crus penis recess 254. In one embodiment, the lip 290 extendsfrom the side surface 284 at an angle in a range from 5-140 degrees. Theangle of the lip 290 allows the adapter 258 to engage with the proximalportion of the cylinder 262.

FIG. 29A is a side view, FIG. 29B is a front view, and FIG. 29C is across-sectional view of the implantable support 254. In one embodiment,a proximal attachment tab 292 is connected to the implantable support254 and configured for attachment to a descending ramus of the person,and a distal attachment tab 294 is connected to the implantable support254 and configured for attachment to a pubic body or a pubic symphysisof the person.

FIG. 29A is a side view of the implantable support 254 illustrating aproximal portion 296 that tapers to a flat plate that is suitable foraffixing to the descending pubic ramus. FIG. 29B is a front viewillustrating that the proximal portion 296 has a frontal area that islarger than the side area illustrated in FIG. 29A. The wider frontalarea of the proximal portion 296 is configured to lie against thedescending ramus in a flattened configuration that is suitable forattachment to either the periosteum or the bone of the pelvis. In oneembodiment, the proximal attachment tab 292 is sutured to the periosteumtissue of the descending ramus, the distal attachment tab 294 is suturedto either the periosteum tissue of the pubic body where the pubicsymphysis, and the reinforcing suture (or stay suture) is suturedthrough the proximal portion 296 of the implantable support 254 toensure that the artificial crus penis recess 256 adopts the anatomicalconfiguration along the ramus of the natal crus penis.

FIG. 29C is a cross-sectional view illustrating the adapter 258 securedinside of the artificial crus penis recess 256. The distal end of theadapter 282 is arranged adjacent to the distal attachment tab 294 andthe proximal end 280 of the adapter 258 is inserted into the taperedregion of the artificial crus penis recess 256. The proximal portion ofthe cylinder 262 (FIG. 27 ) is inserted into the opening at the distalend 282 of the adapter 258 and inserted through the opening formed inthe proximal end 280 of the adapter 258 until the plurality of lips 290clamps radially against the proximal portion of the cylinder 262.

FIG. 30 is a schematic view of a pelvis in the implantable support 254.In one embodiment, the implantable support 254 includes a plurality ofdistal attachment tabs 294, with one of the tabs 294 adapted forattachment to the pubic body and the second of the tabs 294 adapted forattachment to the pubic symphysis. The proximal attachment tab 292 isattachable to the tissue of the descending pubic ramus. Attachment ofthe implantable support 254 along the descending pubic ramusappropriately orients the implantable support 254 to support the penileprosthetic 262 anatomically in the same position as a natal penissuitable for penetrative intercourse.

With reference to FIG. 27 , after attachment of the implantable support254, the surgeon implants the cylinders 262 of the penile prostheticinto the neophallus to form a neopenis. The proximal end 270 of thecylinder 262 is inserted through the adapter 258, and the distal end 272of the cylinder 262 is placed in the distal end of the neophallus. Thereservoir 264 is implanted in a location within the pelvis or within theabdomen, depending upon the preference of the surgeon. The pump 266 isimplanted within the neoscrotum. The cylinders 262 are inflatable byoperation of the pump 266 to move liquid from the reservoir 264 and intothe cylinders 262 to provide the neopenis with an erection. Thereservoir 264, the pump 266, and the tubing 268 are as described in U.S.Pat. Appln. Pub. 2011/0118540, which issued as U.S. Pat. No. 8,337,392,the disclosure of which is incorporated by reference in its entiretyinto this application.

Optionally, the surgeon implants a malleable penile prosthetic that issecured into the implantable support 254.

Embodiments of the implantable support 254 provide a two-piece anchorsystem, where the support 254 is configured to be implanted and attachedto the ramus, and a penile prosthetic is insertable into and retained bythe implantable support 254. For example, in one approach, the surgeonimplants the implantable support 254 in a first surgical procedure andplaces a removable gauze or other filler to maintain the opening in thesupport 254. The patient is allowed to heal. The surgeon subsequentlyimplants a prosthetic into the implantable support 254 in a secondprocedure, for example as the prosthetic is mated to the neophallus.

In one embodiment, the implantable support 254 is formed by thepatient's own tissue in the form of a bone graft anchor. The bone graftanchor is formed by removing a portion of bone from the pelvis from thepatient, for example a portion of the iliac crest, the ilium, theanterior inferior iliac spine, or other another surface of the pelvisthat is accessible during the phalloplasty procedure. The bone isgrafted onto the descending ramus and is adapted to anchor the proximalend portion of a penile prosthetic. In this way, the patient's owntissue is employed to form a structural zone that provides a foundationto support axial forces associated with penetrative intercourse. In oneembodiment, a method of implanting a penile implant to provide a personwho was assigned the female sex at birth with a neopenis suitable forpenetrative intercourse includes harvesting bony tissue during a FTMphalloplasty procedure. The method includes removing a portion of bonefrom one of the iliac crest, the ilium, the anterior inferior iliacspine, or other another surface of the pelvis; grafting the harvestedbone to the ramus in a bone graft and forming a fixation zone with thebone graft; and attaching a penile prosthetic to the bone graft. Themethod can be combined with laparoscopic hysterectomy, joining of thelengthened neourethra to the natal urethra, vaginectomy, glansplasty atthe distal neophallus, placement of testicular prosthetics, ortransposition of the clitoris to the base of the neophallus.

FIG. 31 is a perspective view of one embodiment of a neophallus implantsystem 300 including a penile prosthetic 302 and an implantable support304.

The neophallus implant system 300, when implanted, provides a personwith a neopenis. The penile prosthetic 302 has a shaft 306 connectedbetween a distal end portion 308 and a proximal end portion 310. Thedistal end portion 308 is sized for implantation into the neophallus toform that portion of the neopenis. The implantable support 304 isattachable to a descending ramus of a pelvis, and when implanted,provides an artificial crus penis 304. The proximal end portion 310 ofthe penile prosthetic 302 is coupled to the artificial crus penis 304 tolocate the neopenis (neophallus plus the prosthetic 302) anatomically ina natal penis location.

In one embodiment, the penile prosthetic 306 is inflatable and includesan inflatable tubular body 312 coupled to a reservoir 314 and a pump316. The pump 316 is coupled to the tubular body 312 by a tube 318, andthe pump 316 is coupled to the reservoir 314 by a separate tube 320. Thepump 316 is operable to move liquid retained in the reservoir 314 intothe tubular body 312. The increased volume of liquid in the tubular body312 increases the pressure inside of the tubular body 312 providing thepenile prosthetic 302 with an erect state.

In one embodiment, the tube 318 is coupled to the proximal end portion310 of the penile prosthetic 302 such that the implantable support 304is connected to the penile prosthetic 302 by an inflatable and flexiblehinge 321. In this embodiment, the implantable support 304 provides arigid support that is adapted for surgical attachment to the descendingramus and the penile prosthetic 302 is inflatable to provide theneophallus of the trans-male with an erection. The inflatable andflexible hinge 321 allows a non-linear coupling between the penileprosthetic 302 and the implantable support 304 to allow positioning ofthe neopenis in the trans-male in a location in position of that of apenis in a natal male.

Suitable material for fabricating the tubular body 312 includessilicone, biocompatible polymers such as urethanes, and blends ofpolymers with urethane, copolymers of urethane, or the like.

The reservoir 314 is sized to maintain a volume of liquid between about50-300 ml. In one embodiment, the reservoir 314 is configured to bepressed into a small volume package when empty, which configures thereservoir 314 for implantation into small spaces located within theabdomen of the user. One suitable reservoir 264 is sized to retainapproximately 130 mL of liquid and is available from Coloplast Corp.,Minneapolis, Minn.

In one embodiment, the implantable support 304 is a shaft ofcontinuously solid polymer material that is adapted to provide columnstrength to the penile prosthetic 302. In one embodiment, theimplantable support 304 is a combination of a rigid proximal end portionand a flexible portion 310, which adapts the implantable support 304 tobe bendable and positionable for implantation alongside a descendingpubic ramus of the pelvis.

In one embodiment, the implantable support 304 is a malleable supportincluding a metal core 322, a malleable metal coil 324 wrapped aroundthe metal core 322, and elastomer shaft 326 placed over the core 322 andthe coil 324. In one embodiment, the metal core 322 is formed fromsilver, and the metal coil 324 is a silver coil located around the metalcore 322. In one embodiment, the metal core 322 and the coil 324 areenclosed in a polymer sheath 328 which is covered by the elastomer shaft326. The polymer sheath 328 provides added column strength to theimplantable support 304. One suitable elastomer the elastomer shaft 326is silicone. Suitable polymers for the polymer sheath 328 includepolyester, polyurethane, silicone, or polyolefins.

In one embodiment, the penile prosthetic 302 is integrated with theimplantable support 304. In one embodiment, the penile prosthetic 302 isprovided separately and attachable to the implantable support 304.

During implantation, the implantable support 304 is placed alongside thedescending pubic ramus and secured at one or more locations along thepubic ramus and on the pubic body. Suitable locations for affixing theimplantable support 304 to the pubic ramus include a proximal portion ofthe ramus, a midportion of the ramus, and the pubic symphysis. Suitableattachment of the implantable support to the pubic ramus include suturesplaced through the shaft 326 and the periosteum over the bone of theramus. Other mechanical connections of the implantable support 304 tothe pubic ramus are also feasible, such as textile wraps, or screws,depending upon the surgeon's preference. In any regard, the penileprosthetic 302 extends from the implantable support 304 and is sized forimplantation into a neophallus. The implantable support 304 provides thesystem 300 with an artificial crus penis that supports the penileprosthetic 302. The penile prosthetic 302 is inflatable to provide theperson with an erection. The implantable support 304 provides abackboard or a foundation that allows the inflated prosthetic 302 tohave the strength and durability that is suitable for penetrativeintercourse. The location of the implantable support 304 along the pubicramus, in combination with the inflatable penile prosthetic 302, resultsin locating the neopenis anatomically in a similar or the same locationas a natal penis location relative to the pelvis.

FIG. 32 is a schematic view of one embodiment of an implantable support350 located relative to a pelvis. The implantable support 350 is adaptedto support the single implantable prosthesis 22 (FIG. 3 ) or thedual-cylinder penile prosthetic 302 (FIG. 31 ). The implantable support350 includes a receptacle 352 sized to receive and stabilize theproximal portion of a single implantable prosthesis or both of thedual-cylinder prosthetics. The receptacle 352 forms the artificial cruspenis of the support 350. The implantable support 350 includes a firstconnector 354 and a second connector 356, where the connectors 354, 356are configured to receive the respective proximal end of each of thedual-cylinder prosthetics.

The implantable support 350 includes a first lateral side 360 that isangled and shaped for connection along a length of the patient's rightdescending ramus, a second lateral side 362 that is angled and shapedfor connection along a length of the patient's left descending ramus,and a top side 364 that is sized and shaped to span a distance acrossthe pubic body of the pelvis. The sides 360, 361 may be sutured orconnected to the periosteum over the ramus bone, or may be securedaround a portion or an entirety of the circumference of the ramus. Whensecured by sutures, the support 350 includes mounting holes throughwhich a needle and suture pass to secure the support 350 to the pelvis.The top side 364 may be attached to the periosteum over the pubic body,or to the periosteum over the pubic body and to the pubic symphysis. Thesupport 350 includes a lower side 366 that bridges between the ramusbones to provide a wide area of support that allows the prosthetic, whenimplanted, to have sufficient column strength for penetrativeintercourse.

When implanted, and connected to the pelvis, the receptacle 352 of thesupport 350 receives the proximal end portion of the penile prostheticin the fashion of a crus penis to locate the prosthetics within theneophallus anatomically in a natal penis location.

FIG. 33 is a perspective view, FIG. 34 is a side view, and FIG. 35 is atop view of the implantable support 350 illustrated in FIG. 32 . Theimplantable support 350 has a longitudinal curvature 370 from the topside 364 to the lower side 366 and a lateral curvature 372 between thesides 360, 362. The longitudinal curvature 370 and the lateral curvature372 are convex on the anterior, outer surface of the support 350, suchthat the interior, posterior side of the support 350 is concave. Therelative angles of the sides 360, 362, in combination with thecurvatures 370, 372 configure the support 350 to form an artificial cruspenis recess that projects in an anterior direction from the pelvis. Theartificial crus penis recess provides the trans-male with a structurethat will support a neopenis and allows the receptacle 352 to locate theprosthetic anatomically in a natal penis location. The complex curvature(longitudinal and lateral) of the support 350 provides a shield shapethat allows the support 350 to provide a foundation that supportspenetrative intercourse with the prosthetic(s) of the neopenis.

The implantable support 350 is suitably fabricated from polymer, such aspolypropylene, reinforced polypropylene, nylon, a carbon fiberreinforced polymer, or metal, such as stainless steel.

When implanted, and connected to the pelvis, the receptacle 352 of thesupport 350 functions as a crus penis and receives the proximal endportion of the penile prosthetic, the connector 354 secures the proximalend of one of the right-hand prosthetic, and the connector 356 securesthe proximal end of the left-hand prosthetic. The proximal portions ofthe prosthetics will be aligned along the descending ramus and thedistal end portions of the prosthetics will be received within theneophallus. This orientation will locate the prosthetics within theneophallus anatomically in a natal penis location.

Some prosthetics are slightly shorter in length than desired by thesurgeon for the application. In such a case the surgeon will attach arear tip extender (RTE) to the proximal end portion of the prosthetic togive the prosthetic a length suited to the individual. The connectors354, 356 are configured to receive the RTEs, for example by mechanicalattachment such as a threaded connection, or by surgical connectionthrough suturing the RTE to the connector 354, 356 area.

FIG. 36A is a schematic view of one embodiment of a neophallus implantsystem 400 illustrating a neopenis in a flaccid state, and FIG. 36B is aschematic view of the neophallus implant system 400 with the neopenis inan erect state. The schematic views illustrate a prosthetic implantedinto a neophallus to provide a neopenis that is supported by anartificial crus penis, such as those artificial crus penis recessesdescribed in this application. The artificial crus penis is implanted inthe pelvis and operates to allow the prosthetic to present theneophallus in both the flaccid and erect states, embodiments of whichare described below.

FIG. 37A is a side schematic view of one embodiment of the neophallusimplant system 400. The system 400 includes an artificial crus penis 402supporting a penile prosthetic 404. The neophallus has been formed fromtissue and the penile prosthetic 404 has been implanted in theneophallus. The penile prosthetic 404 includes a proximal end portion406 and a proximal end 408. The artificial crus penis 402 includes abody 410 that is implantable into the pelvis, where the body 410includes an interior surface 412 that defines a recess 414 and anopening 415 for access to the recess 414. A keyhole opening 416 isformed in the interior surface 412 and is sized to receive the proximalend 408 of the penile prosthetic 404, when the proximal end 404 ismanually oriented to a specific orientation by the user.

The penile prosthetic 404 includes several degrees of freedom, includinga pitch direction P in which the penile prosthetic pitches up-and-downwithin the plane of the drawing, a roll direction R in which the penileprosthetic rotates about its longitudinal axis, and a yaw direction Y inwhich the distal end portion of the penile prosthetic 404 moveslaterally into and out of the plane of the drawing.

The user of the implanted penile prosthetic 404 may move the neopenis inseveral directions. The user of the implanted penile prosthetic 404 maymanually move the penile prosthetic 404 in certain specific directions,detail below, that ultimately engage the proximal end 408 of the penileprosthetic 404 within the keyhole opening 416 of the artificial cruspenis 402 to provide the neopenis with an erection.

FIG. 37B illustrates the neophallus in the flaccid state with theproximal end 408 located superior relative to the keyhole opening 416.The keyhole opening 416 includes a gate 418 and a fence 420. The gate418 is a vertical orientation, and the fence 420 has a horizontalorientation. The fence 420 is formed as an opening in the interiorsurface 412 in a location that is posterior to the gate 418. Asdescribed above, the penile prosthetic 404 is movable relative to theinterior surface 412. The proximal end 408 of the penile prosthetic 404may move over the keyhole opening 416 and will not engage with the gate418 until the proximal end 408 also has a vertical orientation thatmatches with the orientation of the gate 418.

FIG. 37C illustrates the proximal end 408 of the penile prosthetic hasbeen rotated in the roll direction R on its longitudinal axis to orientthe proximal end 408 in a vertical orientation that is aligned with thegate 418. Subsequent movement of the proximal end 408 along the interiorsurface 412 will seat the proximal end 408 into the gate 418.

FIG. 37D illustrates the proximal end 408 has been translated and moveddown along the interior surface 412 until the proximal end 408 has beenseated within the gate 418 of the artificial crus penis 402. Additionalmovement in a proximal direction will push the proximal end 408 into andthrough the gate 418.

FIG. 37E illustrates that the proximal end 408 has been inserted intothe gate 418. The proximal end 408 has been moved into the plane of thedrawing, through the gate 418, until the proximal end 408 has droppedinto the fence 420. Rotation of the proximal end 408 to the horizontalorientation aligns the proximal end 408 within the fence 420 toeffectively “lock” the proximal end 408 of the penile prosthetic intothe keyhole opening 416 of the artificial crus penis 402.

FIG. 37F is a schematic illustration of the movement of the penileprosthetic 404 relative to the artificial crus penis 402. The penileprosthetic 404 has been moved in the pitch direction P such that theproximal end 408 has slid along the interior surface 412 to the gate418. The penile prosthetic 404 has been rotated in the roll direction Rcounter-clockwise until the proximal end 408 aligned with the gate 418.Additional movement of the proximal end 408 in a proximal directionmoves the proximal end 408 through the gate 418. The penile prosthetic404 has been rotated clockwise until the proximal end 408 aligns withand engages with the fence 420. The configuration illustrated in FIG.37F maintains the neopenis in an erect state that is suitable forpenetrative intercourse.

FIG. 38 is a perspective view of one embodiment of an implantablesupport 430 including one embodiment of the artificial crus penis 402.The body 410 of the implantable support 430 includes a first side 432that is attachable to a right side ramus and a second side 434 that isattachable to a left side ramus of the patient. The body 410 is oval inboth lateral and longitudinal cross-section with smoothly curved sides.The opening 415 is formed in an anterior surface of the body 410, andthe penile prosthetic 404 projects in a proximal direction through theopening 415 into the recess 414 of the artificial crus penis 402.

The implantable support 430 is suitably fabricated from polymer, such aspolypropylene, reinforced polypropylene, nylon, a carbon fiberreinforced polymer, or metal, such as stainless steel.

Implantation of the implantable support 430 across the ramus bones andinferior relative to the pubic body provides the patient with a supportthat is adapted to support a neopenis anatomically in a natal penisposition that is suitable for penetrative intercourse.

FIG. 39A is a side schematic view of a neophallus implant system 450illustrating a neopenis in a flaccid state, and FIG. 39B is a sideschematic view illustrating the neopenis in an erect state.

The neophallus implant system 450 includes a penile prosthetic 452 andan implantable support 454 that is attachable to a descending ramus of apelvis to provide an artificial crus penis 456 for a patient receiving aneopenis. The implantable support 454 is adapted to resist axial forcesexperienced by the penile prosthetic 452 during penetrative intercourse,to thus form supporting structure that is provided by the crus penis inthe natal male.

The penile prosthetic 452 has a shaft 460 connected between a distal endportion 462 and a proximal end portion 464 that terminates in a proximalend 466. The distal end portion 462 is implantable into a neophallus toprovide the user with a neopenis capable of achieving an erectionsuitable for penetrative intercourse.

In one embodiment, the artificial crus penis 456 of the implantablesupport 454 includes a receptacle 470 providing an opening 472 into arecess 476. The recess 476 is defined by an interior surface 478 andincludes a ridge 480 formed inside of the receptacle 470, where theridge 480 projects away from the interior surface 478. In oneembodiment, the interior surface 478 is smooth and defines an arc of aconstant radius between the ridge 480 and the opening 472 in an areathat is superior to (counter-clockwise) the ridge 480. In oneembodiment, the interior surface 178 includes a well 482 that isinferior to (clockwise) the ridge 480, such that the interior surface478 does not have a constant radius between the ridge 480 and theopening 472 and an area that is under (or inferior) to the ridge 480.

The artificial crus penis 456 is configured to operate such that, whenthe proximal end 466 of the penile prosthetic 452 is superior to theridge 480, the neophallus is in a flaccid state (FIG. 39A).Alternatively, the artificial crus penis 456 is configured to operatesuch that, when the proximal end 466 of the penile prosthetic 452 isinferior to the ridge 480, the penile prosthetic and the neophallus aremaintained in an erect state (FIG. 39B) that adapts the neopenis forpenetrative intercourse.

The penile prosthetic 452 is movable between the down position (flaccidstate) in which the proximal end 466 is superior to the ridge 480, andthe up position (erect state) in which the proximal end 466 is inferiorto the ridge 480 and seated within the well 482. In one embodiment, thepenile prosthetic 452 is provided as a single shaft that is implantedinto a neophallus. An optional embodiment includes providing a dualshaft penile prosthetic 452. The recess 476 is filled, preferably with agel or a high viscosity liquid that dampens rapid movement of theprosthetic 452 to ensure the prosthetic 452 moves in an anatomicallynatural manner. The implant system 450 is configured to allow thepatient to grasp the shaft 460 within the neopenis and move it from afirst desired erect position to an optionally desired flaccid position.The implantable support 454 is adapted to resist the pressures createdin those common angles, or orientations, that are associated withpenetrative intercourse. The interior surface 478 of the artificial cruspenis 456 is suitable for providing multiple locked, or engaged, erectstate positions. In one embodiment, the motion to facilitate movement ofthe penile prosthetic 452 between the flaccid position and the erectposition includes a rotational movement of the shaft 460. In oneembodiment, an asymmetrical configuration of the interior surface 478allows the user to move the shaft 460 variety of selected positions. Inone embodiment, the proximal end portion 464 of the shaft 460 includes aspring that is adapted to bias the proximal end portion 464 relative tothe interior surface 478 of the artificial crus penis receptacle 456 toallow the shaft 460 to compress when moving over the ridge 480 andextend into engagement with the well 482.

In one embodiment, an exterior surface of the artificial crus penisreceptacle 456 includes a material that promotes tissue ingrowth or atextured surface adapted to maintain the position of the implantrelative to the pelvic structure.

It is desirable to seal the recess 476 from the possibility ofundesirable tissue growth into of the implantable support 454. In oneembodiment, a first seal 484 is provided in a superior location betweenthe receptacle 470 and the penile prosthetic 452, and a second seal 486is provided in an inferior location between the receptacle 470 andpenile prosthetic 452. The first seal 484 and the second seal 486 areflexible, elastic, and adapted to stretch as the penile prosthetic 452moves within the opening 472. Suitable materials for the seals 484, 486include silicone or another suitable elastomer.

The penile prosthetic 452 is connected to the seals 484, 486, with theproximal end portion 464 retained in the recess 476, which configuresthe prosthetic 452 to pivot relative to the receptacle 470.

FIG. 39A illustrates the penile prosthetic 452 in a flaccid position inwhich the second seal 486 is compressed and the first seal 484 iselongated (or, in tension). FIG. 39B illustrates the penile prosthetic452 in an erect position in which the first seal 484 is compressed andthe second seal 486 is elongated. The seals 484, 486 seal against thepenile prosthetic 452 and the receptacle 470 to reduce the likelihoodthat tissue will enter and grow within the recess 476 and to prevent thegel or high viscosity liquid (provided to dampen the movement of theprosthetic 452) from escaping the recess 476.

Various advantages of the implantable system 450 include a specificdesign for trans-gender use, a design that is not reliant on the corporacavernosa that are present in the natal male anatomy and not present inthe trans-male pelvis, a design that obviates a reservoir to containliquid and a pump to move the liquid, and a design that is compatiblefor use with those who have limited hand dexterity.

FIG. 40 is a perspective view of one embodiment of an implantablesupport 500 attachable to a female pelvis that has been surgicallyprepared as a trans-male pelvis. The support 500 includes a first plate502, a second plate 504, and a bridge 506 attachable to and extends willbetween the first plate 502 and the second plate 504. The bridge 506includes a receptacle 508 that is adapted to receive a proximal endportion of a penile prosthetic. Thus, in one embodiment the receptacle508 provides an artificial crus penis recess that is adapted to receiveand support a penile prosthetic that is implantable into the trans-male.

The first plate 502 is attachable to the trans-male pelvis, for exampleto the right side descending ramus, and the second plate 504 isattachable to the trans-male pelvis, for example to the left sidedescending ramus. The first plate 502 and the second plate 504 areattachable to the bone of the pelvis through bonding with bone putty orbone cement, through mechanical attachment with screws, or by biologicalbonding in which tissue is encouraged to grow into or onto a surface ofone of the plates, or a combination of these attachment approaches. Inone embodiment, a surface of the plate 502 that is placed in contactwith the ramus includes a set of barbs or other projections that willsecure the plate 502 to the bone of the pelvis. The first plate 502 andthe second plate 504 are suitably fabricated from a polymer, such aspolypropylene or silicone, a metal such as stainless steel, or acomposite structure. The first plate 502 and the second plate 504 areeach provided with multiple attachment locations 510, where theattachment locations 510 include a projection sized to receive thebridge 506 or a recess sized to receive a projection projecting from thebridge 506. The multiple attachment locations 510 provide the surgeonwith options for placement of the bridge 506 to allow the implantationof the penile prosthetic to mirror a natal male orientation.

The bridge 506 include multiple plug sites 512 that are adapted toengage with the multiple attachment locations 510. The multiple plugsites 512 provide the surgeon with adjustable fixation options whenimplanting the support 500. In one embodiment, the bridge 506 is adaptedto allow the surgeon to cut off or remove one or more of the superfluousmultiple plug sites 512 after attachment of the bridge 506 to the firstplate 502 and the second plate 504.

The bridge 506 includes a socket 514 secured between a first arm 516 anda second arm 518. In one embodiment, the receptacle 508 is a taperedconical receptacle formed through a thickness of the socket 514. Themultiple plug sites 512 are provided incrementally along each of thearms 516, 518. The bridge 506 is suitably fabricated from a polymer,such as polypropylene, nylon, silicone, or metal such as stainlesssteel.

FIG. 41 is a front view of one embodiment of an implantable support 520.The implantable support 520 is implantable on the trans-male pelvis tosupport an implanted penile prosthetic in a natal male orientation. Theimplantable support includes a penile crus plate 522, a pair of arms524, 526 extending from the penile crus plate 522, and a pair of ramuslegs 528, 530 extending from the penile crus plate 522. The penile crusplate 522 includes a receptacle 532 that provides an artificial cruspenis recess that is adapted to receive and support the implanted penileprosthetic of a trans-male phalloplasty. The pair of arms 524, 526 areadapted for attachment to the pectineal line of the pelvis on eitherside of the pubic symphysis. In one embodiment, each of the pair of arms524, 526 includes a back plate that is adapted to receive a bone screwfor attachment of the arms 524, 526 to a posterior side of the pectinealline. In one embodiment, each of the arms 524, 526 is provided with acurved clamp profile 534 that adapts the arms 524, 526 for attachment tothe pectineal line. The pair of ramus legs 528, 530 are adapted forattachment to the anterior surface of the descending pubic ramus. In oneembodiment, each of the pair of ramus legs 528, 530 are configured as acurved clamp 536 that is adapted to be clamped around a portion of thedescending pubic ramus to securely hold the implantable support 520relative to the pelvis such that the implanted penile prosthetic isoriented in a natal male position. The implantable support 520 offers alevel of flexibility to the surgeon for location of a proximal end of apenile prosthetic at or below the pubic body of the pelvis. Theimplantable support 520 is adapted to mount on the anterior service ofthe pelvis, anterior to the pubic symphysis. The implantable support 520is secured to, or around, at least one of the pectineal line for thedescending pubic ramus to provide a very secure mount for the proximalportion of the implantable penile prosthetic.

FIG. 42 is a perspective view of one embodiment of the implantablesupport 550. The implantable support 550 includes an anterior face 552opposite a posterior face 554 and a pair of receptacles 556 formed inthe anterior face 552. The pair of receptacles 556 provide a pair ofartificial crus penis recesses that are adapted to receive a proximalportion of an implantable penile prosthetic. The implantable support 550is attachable to a surgically altered trans-male pelvis to provide thetrans-male with a support that will maintain a penile prosthetic and anatal male orientation that allows penetrative intercourse. Oneadvantage of the implantable support 550 is that each of receptacles 556is adapted to receive a proximal end of an implantable penile prostheticof the style that is implantable into a natal male, where one example ofthe implantable penile prosthetic is the TITAN® penile prostheticavailable from Coloplast Corp., Minneapolis, Minn. Thus, the implantablesupport 550 is compatible with the currently available penileprosthetics.

In one embodiment, at least a portion of the posterior face 554 includesa mesh grid 558 that is adapted to allow tissue ingrowth into a portionof the implantable support 550. In one embodiment, the implantablesupport 550 includes a body 560 integrating a stainless steel plate 562,where the stainless steel plate 562 provides a level of rigidity forattachment of the implantable support 550 to the trans-male pelvis. Thebody 560 is suitably fabricated from a flexible polymer, such assilicone. The mesh grid 558 is applied to a posterior side of the body562 encouraged tissue ingrowth into the other components of theimplantable support 550.

FIG. 43 is a perspective view of one embodiment of an implantablesupport 570 having attachment features that allow fixation of thesupport 570 to ligaments and tissue of the pelvis, for example thesacrospinous ligament or tissue of the sacrum. The implantable support570 is analogous to the implantable support 100 described in FIG. 12 andincludes a base 572/102 that is attachable to a pelvis of a personassigned the female sex at birth, and an artificial crus penis recess574/104 connected to the base 572/102. The base 572/102 provides animplant bed that supports the artificial crus penis recess 574/104 toallow a person who was assigned the female sex at birth to have aneopenis that is situated anatomically in the same position as a natalpenis. The base 572/102 and the artificial crus penis recess 574/104share those aspects of the implantable support 100 described in FIG. 12, and thus include common identifying numbers.

The attachment features of the support 570 include anchors that aresecured to the base 572 with the suture. A variety of such anchors areillustrated, including anchors that allow the suture to slide relativeto the anchor, anchors that toggle to engage with tissue, and pushthrough anchors that are suitable for insertion into tissue such asligaments that are out of the line of sight of the surgeon. Theillustrated anchors are exemplary embodiments. In one embodiment, a setof toggling anchors 580 is attached to the base 572 by sutures 582, anda set of adjustable sliding anchors 584 are attached to the base 572with separate sutures 586.

The toggling anchors 580 are as described in U.S. Pat. Appln. Pub.2016/0157845, which issued as U.S. Pat. No. 9,510,822, the disclosure ofwhich is incorporated by reference in its entirety into thisapplication.

The adjustable sliding anchors 584 are as described in U.S. Pat. Appln.Pub. 2010/0198003, which issued as U.S. Pat. No. 8,585,578, thedisclosure of which is incorporated by reference in its entirety intothis application.

In one embodiment, the support 570 is secured to the patient byattaching one or more anchors to the sacrum and two or more anchors tothe tissue of the obturator foramen. In one embodiment, the support 570is secured to the patient by attaching one or more anchors to thesacrospinous ligament and one or more anchors at or near the tissue ofthe obturator foramen.

The surgeon may find it useful to insert the toggling anchors 580 intotissue associated with the obturator foramen, and employ the sutures 582to adjust the tension between the anchor 580 and the base 572. In thissense, the lateral edge 112 would be an inferior edge, or bottom, of thebase 572. The surgeon may find it useful to insert the adjustablesliding anchors 584 into a ligament, such as a sacrospinous ligament,and employ the suture 586 to adjust the tension between the anchor 584and the base 572. The artificial crus penis recess 574 supports aportion of the implantable penile prosthetic and optionally includes apush through anchor 588 secured to the base 572 by a suture 590. It isacceptable to insert the adjustable sliding anchors 584 into tissue ofthe obturator foramen, and insert the toggling anchors 580 into perineumtissue covering the bone of the pelvis or into a ligament within thepelvis. The push through anchor 588 provides additional support to theproximal end of the artificial crus penis recess 574. This approach tofixation of a penile prosthetic in the trans-male pelvis advantageouslyemploys landmarks that are familiar to the surgeons who implant supportsto treat pelvic organ prolapse in the natal female. The multiplefixation points provided by the multiple anchors 580, 584, 588 and thebase 572 provided durable and flexible fixation that adapts the support570 to withstand the axial forces associated with penetrativeintercourse.

FIG. 44 is a perspective view of one embodiment of a kit of parts 600.The kit of parts 600 includes an implantable support 602, an implantablepenile prosthetic 604, and an artificial glans 606. In one embodiment,the implantable support 602 is similar to the implantable support 550(FIG. 42 ), although modified to have a single artificial crusreceptacle 556′. The implantable support 602 is adapted to support theimplantable penile prosthetic 604/22 in the pelvis of a trans-male in anorientation of that of a natal male penis. In one embodiment, theimplantable penile prosthetic 604 is similar to the single cylinderimplantable penile prosthetic 22 (FIG. 3 ). The artificial glans 606 isattachable to the distal end portion 34 of the implantable penileprosthetic 604/22. The artificial glans 606 is a synthetic cap portionthat is attachable over the distal end 36 of the implantable penileprosthetic 604/22 inside the distal portion of the neophallus. The kitof parts 600 is supplied to a surgeon in a single, sterile package thatprovides the healthcare facility with components that are suited toimplant and support a penile prosthetic in a trans-male after aphalloplasty procedure.

The single shaft 41 of the implantable penile prosthetic 604/22 isinflatable with liquid retained in the reservoir 28. The proximal endportion 38 of the penile prosthetic 604/22 is sized for insertion intothe artificial crus penis receptacle 556′ of the implantable support602. The distal end portion 34 of the implantable penile prosthetic604/22 is sized for insertion into a mating recess 608 formed within theartificial glans 606. The implantable penile prosthetic 604/22 and theartificial glans 606 are adapted for implantation into a surgicallyformed neophallus after the newly formed neophallus has healed.

FIG. 45 is a perspective view of one embodiment of a kit of parts 610.The kit of parts 610 includes an implantable support 550 (see FIG. 42 ),an implantable penile prosthetic 252 including two inflatable cylinders271 (see FIG. 27 ), and an artificial glans 616. The implantable support550 is adapted to support the implantable penile prosthetic 252 in thepelvis of a trans-male in an orientation of the natal male. Theimplantable penile prosthetic 252 includes dual inflatable cylinders271, each having a proximal end 270 that is sized for insertion into oneof the artificial crus penis receptacles 556, and a distal end 272 thatis sized for insertion into mating recesses 618 of the artificial glans616. One suitable implantable penile prosthetic 252 is the TITAN® penileprosthetic available from Coloplast Corp., Minneapolis, Minn. The kit ofparts 610 is supplied to a surgeon in a single, sterile package thatprovides a healthcare facility with components that are suited toimplant and support a dual cylinder penile prosthetic and a trans-maleafter a phalloplasty procedure.

FIG. 46 is a perspective view of one embodiment of a kit of parts 620.The kit of parts 620 includes an implantable support 550 (see FIG. 42 ),a pair of implantable, malleable penile prosthetics 624, and anartificial glans 626. The implantable, malleable penile prosthetic 624includes a first malleable prosthetic 630 and a second malleableprosthetic 632. Each of the first and second malleable penile prosthetic630, 632 includes a silicone elastomer shaft 634 surrounding a silverwire coil 636 that is wound around a silver wire core 638, where thecore 638 and coil 636 are contained within a polymer 640, such as apolyester or a polyethylene terephthalate. In one embodiment, bothportions are over-molded with the silicone shaft 634 to form a body ofthe malleable penile prosthetic 624. In one embodiment, a hydrophiliccoating is applied to the exterior surface of the malleable penileprosthetic 624. In one embodiment, the hydrophilic coating functions toabsorb an antimicrobial agent that is applied to the exterior surface ofthe malleable penile prosthetic 624 prior to implantation. In oneembodiment, an antimicrobial or prophylactic coating is applied to theexterior surface of the malleable penile prosthetic 624. The silver wirecoil 636 and core 638 allows the malleable prosthetic 624 to be bent bythe user between an erect position (second state) for penetrativeintercourse and a lowered flaccid position (first state). Suitablemalleable penile prosthetic includes the GENESIS® malleable penileprosthetic available from Coloplast Corp., Minneapolis, Minn. Each ofthe first and second malleable penile prosthetic 630, 632 includes aproximal end 642 that is sized for insertion into one of the artificialcrus penis receptacles 556, and a distal end 644 that is sized forinsertion into mating recesses 646 of the artificial glans 626. The kitof parts 620 is supplied to a surgeon in a single, sterile package thatprovides a healthcare facility with components that are suited toimplant and support a dual cylinder penile prosthetic and a trans-maleafter a phalloplasty procedure.

FIG. 47A is a perspective view and FIG. 47B is a cross-sectional view ofone embodiment of an implantable penile prosthetic 650. The trans-malepatient does not have a tunica to support the erectile member of thepenis as is found in the natal male (see FIG. 1C). The implantablepenile prosthetic 650 offers a solution to the trans-male patient tohave an implantable component that offers an erection and an artificialtunica portion. In one embodiment, the implantable penile prosthetic 650includes a pair of malleable penile inserts 630, 632 encased in anartificial tunica 652. Each of the pair of malleable penile inserts 630,632 is as described above in FIG. 46 , and includes the siliconeelastomer shaft 634 surrounding the silver wire coil 636 that is woundaround the silver wire core 638, where the core 638 and coil 636 arecontained within the polymer 640. The artificial tunica 652 is moldedaround both malleable penile inserts 630, 632 and includes alongitudinal trough 654 extending along an entire length of theartificial tunica 652. The longitudinal trough 654 is adapted to receivethe neourethra that is formed during the phalloplasty procedure. Themalleable penile inserts 630, 632 are adapted to be bent by the userbetween an erect position, and a relaxed (non-erect) position. Theartificial tunica 652 is also adapted to be malleable to move with bothpenile inserts 630, 632. The artificial tunica 652 is formed from amalleable and flexible polymer, such as an elastomer, or anothersilicone. The implantable penile prosthetic 650 includes a proximal end656 that is adapted to be inserted into one of the implantable supportsdescribed above, or otherwise attached to the descending ramus of thetrans-male pelvis. The proximal end 656 of the implantable penileprosthetic 650 is thus supported by the pelvis and is enclosed in theneophallus. The artificial tunica provides the means for reducingerosion of an implanted penile prosthetic through the neophallus of aneopenis implanted in a trans-male. The artificial tunica provides themeans for supporting the implanted penile prosthetic within theneophallus of the trans-male. The artificial tunica provides the meansfor reducing or preventing the movement of the implanted penileprosthetic within the neophallus off of the longitudinal axis of theneophallus.

The implantable penile prosthetic 650 is implanted into the patient inone of the stages of the FTM phalloplasty procedure. The phalloplastyprocedure can include multiple steps, such as laparoscopic hysterectomy,joining of the lengthened neourethra to the natal urethra, avaginectomy, a glansplasty at the distal neophallus, placement oftesticular prosthetics, and transposition of the clitoris to the base ofthe neophallus. In one embodiment, a temporary and removable place saveris implanted into the neophallus to maintain an opening in theneophallus that is sized to subsequently receive the implantable penileprosthetic 650. The place saver is an object, such as an oblong balloon,that occupies an interior cavity formed in the neophallus. In oneembodiment, the implantable penile prosthetic 650 is implanted into thephalloplasty as one of the multiple steps.

FIG. 48 is a perspective view of one embodiment of a neophallus implantsystem 700. The implant system 700 includes an inflatable penileprosthetic 702, an artificial septum 704, and an artificial crus recesssupport 706. The trans-male pelvis is surgically altered to include aneophallus, but the neophallus does not include the tunica thatsurrounds the erectile tissue or a septum that separates one corporacavernosum from an adjacent corpora cavernosum (see FIG. 1C). It isdesirable to provide the trans-male patient with a neophallus thatincludes an effective penile prosthetic having as many characteristicsof the natal male penis as possible. The artificial septum 704 providesa structure that supports the penile implants, provides a septum toseparate the inflatable prosthetics of the penile implant, and providesa level of rigidity associated with the natal male penis. The artificialseptum 704 provides the means for reducing erosion of an implantedpenile prosthetic through the neophallus of a neopenis implanted in atrans-male. The artificial septum 704 provides the means for supportingthe implanted penile prosthetic within the neophallus of the trans-male.The artificial septum 704 provides the means for reducing or preventingthe movement of the implanted penile prosthetic within the neophallusoff of the longitudinal axis of the neophallus.

The inflatable penile prosthetic 702 includes a reservoir 710 that isadapted to hold a volume of liquid, a pump 712 that is adapted to movethe liquid out of the reservoir 710, and a pair of inflatableprosthetics including a first inflatable penile prosthetic 714 and asecond inflatable penile prosthetic 716 that are coupled to thereservoir 710 in the pump 712 by tubing 718. One suitable implantablepenile prosthetic 252 is the TITAN® penile prosthetic available fromColoplast Corp., Minneapolis, Minn.

The artificial septum 704 includes a longitudinal body 720 that extendsbetween a proximal end 722 and a distal end 724, and a plurality ofclasps 726 that are adapted to secure the first and second inflatablepenile prosthetics 714, 716 to the artificial septum 704. In oneembodiment, the longitudinal body 720 is formed to include alongitudinal trough 730 that extends an entire length between theproximal and distal ends 722, 724. The longitudinal trough 730 isadapted and sized to receive a neourethra of the neophallus. In oneembodiment, the proximal end 722 of the artificial septum 704 is adaptedto engage with the support 706, where the support 706 includes any ofthe supports described in this application, two examples of whichinclude the support 84 (FIG. 11A) or the support 220 (FIG. 25 ). In oneembodiment, the distal ends 724 of the artificial septum 704 has abulbous shape 732 that provides stability at the distal end of thepenile prosthetic 702 as well as lateral support to each of theinflatable penile prosthetics 714, 716. In one embodiment, the clasps726 are adjustable clasps that have an adjustable diameter that can besecured around a diameter of each of the inflatable penile prosthetics.The clasps 726 include elastic clasps that stretch as the inflatablepenile prosthetics 714, 716 inflate and expand. The proximal end 722 hasa bulbous shape that expands laterally to provide support to the taperedproximal ends of each of the inflatable penile prosthetics 714, 716. Thebody 720 of the artificial septum 704 is adapted to have a level offlexibility similar to the flexibility of the flaccid male penis, forexample by being molded from an elastomeric polymer. The body 720 alsosupports the inflatable penile prosthetics 714, 716 to provide theinflatable penile prosthetic 702 with a level of longitudinal rigiditywhen the inflatable penile prosthetics 714, 716 are inflated. Onesuitable material for the formation of the artificial septum 704includes silicone, where the clasps 726 are monolithically formed to thebody 720. A suitable silicone includes a silicone elastomeric polymerhaving a durometer of 50-60 Shore A. Alternatively, the clasps 726 maybe added to the body 720 separately. Although FIG. 48 illustrates twoclasps 726 on each lateral side of the body 720, it is to be understoodthat a single clasp on each side of the body 720 in the shape of asleeve such as the implantable support 200 (FIG. 23A) is acceptable, asare three or more clasps on each side of the body 720.

FIG. 49A is a perspective view of one embodiment of an implantablesupport 750, and FIG. 49B is a perspective view of one embodiment of theimplantable support 200 (FIG. 23A). Embodiments described below includefabricating each of the implantable supports 750, 200 through 3-Dprinting with expanded polytetrafluoroethylene (ePTFE).

The implantable support 750 includes a sleeve 752 provided with a recess754 and a base that is provided with securement flaps 756. At least thesleeve 752 of the implantable support 750 is porous, where the remainderof the sleeve is fabricated by 3-D printing the ePTFE. In oneembodiment, at least the sleeve 752 of the implantable support 750 isseeded with tissue growth factors to encourage tissue growth through thesleeve 752. The recess 754 is sized to receive an implantable penileprosthetic, such as the inflatable style of penile prosthetic or themalleable style of penile prosthetic described above. The securementflaps 756 are adapted to be secured to the periosteum tissue that coversthe bone of the pelvis, for example the ramus, to provide theimplantable support 750 with an artificial fundiform ligament. To thisend, the securement flaps 756 contribute to anchoring the implantablesupport 750 in the orientation associated with the natal male penis. Theimplantable support 750 is adapted for insertion into a neophallus of atrans-male pelvis, either before or after a penile prosthetic is securedwithin the recess 754.

The implantable support 200 of FIG. 49B is described above in FIG. 23and includes the sleeve 212 that has an opening 214 into the recess 204,where the recess 204 is sized to receive a penile prosthetic. The base202 is analogous to the securement flaps 756, and are described above inFIG. 23 . In one embodiment, the implantable support 200 is fabricatedby 3-D printing with ePTFE, where at least the sleeve 212 is porous toencourage tissue ingrowth. In one embodiment, at least the sleeve 212 isseeded with tissue growth factors. The implantable support 200 isadapted to receive one implantable penile prosthetic. The implantablesupport 220 (FIG. 25 ) is adapted to receive two implantable penileprosthetics. In one embodiment, the dual style support 220 is fabricatedby 3-D printing with ePTFE, where at least the sleeve portion 232 isporous to encourage tissue ingrowth. In one embodiment, at least thesleeve 232 is seeded with tissue growth factors.

Embodiments of the implantable supports 750, 200, 220 provide theneopenis of the trans-male with an artificial tunica that provideslateral and longitudinal support to whichever style of implantablepenile prosthetic is selected by the surgeon. The artificial tunicaprovides the means for reducing erosion of an implanted penileprosthetic through the neophallus of a neopenis implanted in atrans-male. The artificial tunica provides the means for supporting theimplanted penile prosthetic within the neophallus of the trans-male. Theartificial tunica provides the means for reducing or preventing themovement of the implanted penile prosthetic within the neophallus off ofthe longitudinal axis of the neophallus.

FIG. 50A is a perspective view of one embodiment of an implantablesupport 770. FIG. 50B is a cross-sectional view of one half of theimplantable support 770 of FIG. 50A.

Implantable support 770 includes a first portion 772 that meets with asecond portion 774 to provide a passageway 776 for a neourethra 778formed during a phalloplasty procedure with a trans-male patient. Thefirst portion 772 is formed to have a cross-sectional kidney shapedprofile that is symmetric with a kidney shaped profile of the secondportion 774. The implantable support 770 includes a proximal end portion780 that is adapted to be coupled to a proximal end 782 thatcommunicates with a pump and a reservoir at 784, similar to the systemillustrated in FIG. 48 . The implantable support 770 includes a distalend portion 790 that is insertable into the neophallus, and in oneembodiment is adapted to be coupled to an artificial glans 792. Thecombination of the implantable support 770, the proximal end 782, andthe artificial glans 792 are adapted to provide the trans-male with animplantable neophallus system that will provide the trans-male with aneopenis that is suitable for penetrative intercourse. In oneembodiment, the first portion 772 and the second portion 774 areinflatable with liquid supplied by the reservoir and are suitably formedfrom an elastomeric polymer system, examples of which includepolyurethane or silicone.

FIG. 50B is a cross-sectional view of the first portion 772 where a wall794 has been reinforced with a composite structure 796. In oneembodiment, the wall 794 is fabricated from an elastomeric polymer andthe composite structure 796 is a reinforcing mesh. The reinforcing meshis suitably selected from polymeric meshes formed from polypropylene,nylon, polyurethane, polyethylene, or other elastomeric materials. Thecomposite structure 796 provides a limit stop to the lateral expansionof the wall 794 of the first portion 772 to thus provided an analogousstructure to the tunica of the natal male penis.

FIG. 51A is a perspective view of one embodiment of a neophallus implant800. The neophallus implant 800 includes a spine 802 supporting a firstinflatable penile prosthetic 804 and a second inflatable penileprosthetic 806, and an artificial glans penis 808. The neophallusimplant 800 is implantable into a neophallus of a trans-male to providethe trans-male with a neopenis that is suitable for penetrativeintercourse. Embodiments include fixation of the proximal end portion ofthe neophallus implant 800 to an appropriate implantable support, suchas any one of those described above, to allow the neophallus implant 800to have the orientation of a natal male penis and to support penetrativeintercourse.

FIG. 51B is a perspective view of the spine 802. The spine 802 includesa first portion 810 and a second portion 812. The first portion 810includes a first concave surface 814 adapted to receive the firstinflatable prosthetic 804 and a second concave surface 816 adapted toreceive the second inflatable prosthetic 806. Located between the firstconcave surface 814 and the second concave surface 816 is a thirdconcave surface 818. The third concave surface 818 is adapted to receivea neourethra of the neophallus created for the trans-male. The secondportion 812 of the spine 802 is symmetric to the first portion 810 andincludes a first concave surface 824, a second concave surface 826, anda third concave surface 828 that are symmetric and complementary to theconcave surfaces 814, 816, 818, respectively. The first portion 810 isadapted to snap together with the second portion 812 at location 830,for example by a snap-fit coupling. The spine 802 provides a semi-rigidelongate body that supports the neophallus implant 800 and both protectsand supports the neourethra of the trans-male.

FIG. 51C is a cross-sectional view of the proximal portion of theneophallus implant 800. The first portion 810 has been snapped togetherwith the second portion 812 such that the concave surfaces 818, 828combine to form a recess 832 that is sized to receive the neourethra.The concave surfaces 814, 824 combine to provide a supporting surfacethat is sized to receive the inflatable prosthetic 804. The concavesurfaces 816, 826 combine to provide a supporting surface that is sizedto receive the inflatable penile prosthetic 806. One suitable materialfor forming the spine 802 is a silicone material with a suitabledurometer to allow movement of the neophallus between an erect positionin a flaccid position.

FIG. 52 is a perspective view of one embodiment of a neophallus implantsystem 850. The neophallus implant system includes the reservoir 28 andthe pump 30 connected to a penile prosthetic 852 by the tubing 32. Thereservoir 28, the pump 30, and the tubing 32 are as described in U.S.Pat. Appln. Pub. 2011/0118540, which issued as U.S. Pat. No. 8,337,392,the disclosure of which is incorporated by reference in its entiretyinto this application.

The penile prosthetic 852 includes a malleable core 854 retained insideof an inflatable implant 856. The malleable core 854 is similar to themalleable prosthetics described above, and includes a silicone elastomershaft 860 surrounding a silver wire coil 862 that is wound around asilver wire core 864, where the silver wire core 864 and coil 862 arecontained within a polymer 866.

The inflatable implant 856 includes an inflatable bladder 870 thatcommunicates with the reservoir 28 and the pump 30 by a tube connector872. The liquid retained inside of the reservoir 28 is moved by the pump30 into the inflatable bladder 870, and subsequent pumping motionincreases the pressure within the inflatable bladder 870.

In one embodiment, the penile prosthetic 852 has a proximal end 880 thatis defined by the malleable core 854 and a distal end 882 that isprovided by an artificial glans penis 884. In one embodiment, theartificial glans penis 884 is integrated with a distal end of themalleable core 854. The inflatable bladder 870 extends a distance in theproximal direction beyond the tube connector 872 and is connected to themalleable core 854 by a fluid tight bond. The malleable core 854provides enhanced column strength and girth for the penile prosthetic852. The inflatable implant 856 provides enhanced fullness and animproved erection.

The neophallus implant system 850 is compatible with implantation alongwith any of the implantable supports described above, and thus providethe trans-male with a neopenis that functions and has an orientation,after implantation, of that of the natal male penis.

FIG. 53 is a perspective view of one embodiment of a kit of parts 900suitable for a phalloplasty procedure. The kit of parts includes acutting jig 902 that offers utility to a surgeon to customize theproximal tip angle for an inflatable cylinder 271 if employed to treaterectile dysfunction in a natal male. For example, the surgeon maydecide to adjust the proximal tip angle for an inflatable cylinder 271to accommodate a necrotic crus penis recess. The implantable penileprosthetic 252 has been described above in FIG. 27 . Surgeons havedeveloped familiarity and techniques for implanting this style of theimplantable penile prosthetic 252.

The neophallus of the trans-male is constructed from the patient's owntissue. It can be desirable to have the ability to customize aspects ofthe implantable penile prosthetic 252 to more closely agree with thenewly created anatomy in the trans-male. The cutting jig 902 allowscustomization of the proximal portion of the inflatable cylinder 271during a phalloplasty procedure.

In embodiment, the implantable penile prosthetic 252 includes the dualinflatable cylinders 271, each having the proximal end 270 that is sizedfor insertion into one of the artificial crus penis receptaclesdescribed above 556. One suitable implantable penile prosthetic 252 isthe TITAN® penile prosthetic available from Coloplast Corp.,Minneapolis, Minn. The proximal end 270 includes a pointed portion 904.It is desirable in some cases to shorten the length of the proximal end270 of the inflatable cylinder 271 by inserting the proximal end 270into the cutting jig 902 and cutting along the face 906. It is desirablein some cases to alter an attachment angle of the proximal end 270 ofthe inflatable cylinder 271 by inserting the proximal end 270 into thecutting jig 902 and cutting along the face 908. The cutting jig 902allows the surgeon to shorten the length of the inflatable cylinder 271and to adjust the contact angle of the proximal end 270 by adjusting theangle of the proximal end 270 of the inflatable cylinder 271. Thesurgeon may desire to shorten the length of the inflatable cylinder 271depending upon the location of the implanted artificial crus penisreceptacle. The surgeon may desire to adjust the contact angle of theproximal end 270 of the inflatable cylinder 271 depending upon the archangle of the pelvis, as measured between the pair of descending rami forthe patient. The cutting jig 902 allows the surgeon to shape theproximal end 270 by adjusting a length in the angle of the pointedportion 904.

FIG. 54 is a perspective view of one embodiment of a neophallus implantsystem 920. The neophallus implant system 920 includes a reservoir 922that is configured to contain a volume of liquid, a pump 924 that isconfigured to move the liquid out of the reservoir 922 and into thepenile prosthetic 926. Flexible tubing 928 is adapted to connect thereservoir 922 and the pump 924 to the penile prosthetic 926.

The penile prosthetic 926 includes an inflatable distal portion 930connected to a base 934. The base is attachable relative to the pelvisof a trans-male by the anchors 936. In one embodiment, the anchors 936are adjustable anchors that are adapted to adjust the tension of theimplant system 920 by moving any biaxial direction along a length of astrand 938. One suitable strand 938 is a polypropylene suture strand.

The reservoir 922 is sized to maintain a volume of liquid between about50-300 ml and is adapted for implantation into the abdomen of the user,ectopically under the skin and anterior of the rectus sheath, in thespace that was formerly the vaginal vault, or in the space of Retziusdepending upon the procedure and the preference of the surgeon. Onesuitable reservoir 28 is sized to retain approximately 130 mL of liquidand is available from Coloplast Corp., Minneapolis, Minn.

The pump 924 is as described in U.S. Pat. Appln. Pub. 2007/0142700,which issued as U.S. Pat. No. 8,167,788, the disclosure of which isincorporated by reference in its entirety into this application.

The adjustable anchors 936 are as described in U.S. Pat. Appln. Pub.2010/0198003, which issued as U.S. Pat. No. 8,585,578, the disclosure ofwhich is incorporated by reference in its entirety into thisapplication.

FIG. 55 is a cross-sectional view of one embodiment of the penileprosthetic 926. The inflatable distal portion 930 is provided by anelastomeric wall 940 that defines a cavity 942. The cavity 942 receivesthe liquid from the reservoir 922 (FIG. 54 ), which operates to inflateand pressurize the elastomeric wall 940. In one embodiment, a bulbousartificial glans penis is provided on a distal end 944 of the inflatabledistal portion 930. A proximal portion 946 of the inflatable distalportion 930 is coupled with the base 934. Suitable material for theinflatable distal portion 930 include elastomeric polymers, of whichsilicone is one example. The proximal portion 946 is provided as a solidcross-sectional portion that provide support and rigidity to the distalend portion 930.

The base 930 includes a bracket 948 extending from a flange 950, wherethe bracket 948 is integrated with the proximal portion 946 of theinflatable distal portion 930. In one embodiment, the base 934 includeseyelets 952 that are adapted to receive the strands 938 (FIG. 54 ).

Regarding FIG. 54 and FIG. 55 , the base 934 is generally shaped toextend the distance between the descending pubic rami across the pubicarch of the trans-male. The adjustable anchors 936 are provided tofixate the neophallus implant 920 into the soft tissue of the pelvis,for example into the membrane of the obturator foramen, or into aligament, such as the Cooper's ligament. At least one of the adjustableanchors 936 is generally attached to one side of the base 934 and atleast one adjustable anchor 936 is attached to an opposite side of thebase 934. In one embodiment, two adjustable anchors 936 are securedthrough eyelets 952 of the base 934 on each lateral side of theneophallus implant system 920, for a total of at least four anchors. Twoof the adjustable anchors 936 are desirably attachable to the membraneof the obturator foramen. The other of the two adjustable anchors 936are desirably attached to either the membrane of the obturator foramenor to a ligament.

The neophallus implant system 920 is adapted for attachment to thepelvis of the trans male, where the base 934 provides support to allowpenetrative intercourse and aids in the placement of the neophallusimplant system 920 in an orientation that replicates the penis in anatal male.

FIG. 56 is a perspective view of one embodiment of a neophallus implant1000. The neophallus implant 1000 includes a distal tubular portion1002, a first proximal portion 1004, and a transfer joint 1006 connectedbetween the distal tubular portion 1002 and the first proximal portion1004. The neophallus implant 1000 is illustrated in an assembled statein which the transfer joint 1006 has been attached to the distal tubularportion 1002 and the first proximal portion 1004.

In one embodiment, the distal tubular portion 1002 is provided as aninflatable prosthetic having a distal end 1010 and a glans portion 1012;the first proximal portion 1004 is provided as an inflatable prosthetichaving a rear tip portion 1014 coupled to an inflatable portion 1016,with a liquid port 1018 coupled to the inflatable portion 1016. Thetransfer joint 1006 has a distal end 1020 connected to the distaltubular portion 1002, a first proximal end 1022 connected to the firstproximal portion 1004, and a body 1024 extending continuously from thedistal end 1020 to the proximal end 1022.

In one embodiment, the body 1024 of the transfer joint 1006 is formed tohave a fixed bend 1026. The fixed bend 1026 is configured to orient thedistal tubular portion 1002 at an obtuse angle 1028 relative to thefirst proximal portion 1004. The fixed bend 1026 is formed into thetransfer joint 1006 to ensure that the transfer joint 1006 ispermanently bent and to suitably orient the implant to provide aneopenis with a conformation of that of a natal male penis. The fixedbend 1026 positions the distal tubular 1002 portion at an offset anglerelative to the first proximal portion 1004. The complement to theobtuse angle 1028 is a half arch angle HAA illustrated in FIG. 57 . Thetransfer joint 1006 has an angle that aligns the distal tubular portion1002 off of a longitudinal axis of the first proximal portion 1004.Thus, the fixed bend 1026 accommodates the curvature for the implantallowing the proximal portion to be fixated within the pelvis alongsidethe ramus and allowing the distal portion to be offset from the proximalportion and to extend away from and be centered on the body of thetrans-male. The transfer joint 1006 allows the first proximal portion1004 to angle in a direction into the pelvis and away from the centerline of the patient, while maintaining the distal portion on that centerline of the patient.

In one embodiment, the body 1024 of the transfer joint 1006 is flexibleto allow the surgeon to bend the body 1024 to achieve a desired anglethat will orient the first proximal portion 1004 along the ramus and thedistal tubular portion 1002 anterior the pubic body. For example, asuitably bent body 1024 will orient the distal tubular portion 1002 atan obtuse angle 1028 relative to the first proximal portion 1004. Theflexibility of the transfer joint 1006 is achieved by providing anaccordion pleat, for example, or another flexible surface for thetransfer joint 1006 that will allow the transfer joint 1006 to be bentat the half arch angle HAA (FIG. 57 ) to suitably orient the implant toprovide a neopenis with a conformation of that of a natal male penis. Inone embodiment, the transfer joint 1006 is formed from an elastomericpolymer that allows the joint 1006 to be bent to a desired non-zero (andnon-180 degree) angle, and the surgeon subsequently fixates the implant1000 into the body with the transfer joint 1006 in that desired angle.The flexibility of the transfer joint 1006 is adapted to position thedistal tubular 1002 portion at a trans-male pelvic half arch angle HAArelative to the first proximal portion 1004. The transfer joint 1006angle will align the distal tubular portion 1002 off of a longitudinalaxis of the first proximal portion 1004. Thus, the angle of the transferjoint 1006 accommodates a curvature for the implant allowing theproximal portion to be fixated within the pelvis alongside the ramus andallowing the distal portion to be offset from the proximal portion andto extend away from the center line of the body of the trans-male. Thetransfer joint 1006 allows the first proximal portion 1004 to angle in adirection into the pelvis away from the center line of the patient,while maintaining the distal portion on that center line of the patient.

In one embodiment, the distal tubular portion 1002 is provided as amalleable penile prosthetic (not inflatable) and the first proximalportion 1004 is provided as one of a rigid plastic or metal rod or amalleable penile prosthetic. Suitable malleable penile prostheticincludes the GENESIS® malleable penile prosthetic available fromColoplast Corp., Minneapolis, Minn. The transfer joint 1006 couples theportions 1002, 1004 together in an angled fashion where the firstproximal portion 1004 is oriented for attachment to a descending ramusand the distal tubular portion 1002 has an orientation adapted forinsertion into a neophallus.

Penile implants for the natal male penis are generally straight tubularshaped devices (i.e., linear along a longitudinal axis) and sized forinsertion into an existing crus penis recess through the corpuscavernosum. The corpora cavernosa, the crura penis, and the tunicae ofthe natal male penis provide support and resist off-axis bending of theimplanted penile implant laterally relative to the axis of the penis.Sometimes dual inflatable implants are implanted in the male penis totreat erectile dysfunction, and the tunica supports the dual inflatableimplants to prevent either implant from crossing inside of the tissue ofthe penis.

The trans-male anatomy does not have corpora cavernosa, the crura penis,or the tunicae. Thus, the penile implants for the natal male are notwell suited for implantation into the pelvis of the trans-male since thesupporting structure of the natal male is absent. One consequence ofthis anatomical reality for the trans-male pelvis is that a penileimplant designed for the natal male may not have adequate support toallow for penetrative intercourse after implantation into thetrans-male. Embodiments provide a transfer joint 1006 that allows theimplantation of a penile implant into a trans-male pelvis alongside, oradjacent, to the descending ramus in a configuration that supports theproximal portion and the transfer joint of the penile implant tofacilitate penetrative intercourse. The transfer joint 1006 provides themeans for coupling a proximal portion of a penile implant to a distalportion of a penile implant, such that when the neophallus implant isimplanted, the proximal portion is supported to allow for penetrativeintercourse and the distal portion is oriented in a position associatedwith the position of a penis of a natal male. The transfer joint 1006provides the means for associating a proximal portion of a penileimplant in a supporting location adapted to withstand the axial thrustassociated with penetrative intercourse, and aligning a distal portionof the penile implant off of the longitudinal axis of the proximalportion to assume a natural position that is associated with theposition of a penis of a natal male. The transfer joint 1006 providesthe means for coupling a proximal support of a neophallus implant to adistal portion of the neophallus implant, where the proximal support isconnected to a portion of the pelvis and the distal portion is implantedinside of the neophallus for penetrative intercourse.

In one embodiment, the distal tubular portion 1002 and the inflatableportion 1016 are fabricated as an expandable tube or balloon that isadapted to expand when inflated with a liquid that is injected throughthe liquid port 1018. The liquid port 1018 is attachable to a reservoirthat contains liquid and a pump that is provided to move the liquid outof the reservoir and into the implant 1000. A suitable reservoir and asuitable pump are described above in FIG. 54 . The reservoir and thepump are typically coupled to the implant 1000 after first placing theimplant 1000 within the tissue of the neophallus and connecting thefirst proximal portion 1004 to the pelvis.

In one embodiment, the distal tubular portion 1002 has a diameter D1002that is larger than a diameter D1004 of the first proximal portion 1004.In other words, the first proximal portion 1004 is narrower than thedistal tubular portion 1002. The smaller diameter D1004 of the proximalportion can improve comfort after implantation while providingsufficient anchoring support for the neophallus implant 1000. Thediameter D1004 of the proximal portion 1004 has a range from 0.5-1.5 cm.The diameter D1002 of the distal tubular portion 1002 is selected tohave a girth to fill the neophallus, and the diameter D1002 is generallyabout two times as large as the diameter of a penile prosthetic for anatal male penis. The diameter D1002 of the distal tubular portion 1002is a range from 1-4 cm.

The neophallus implant 1000 is implantable within a neophallus toprovide a trans-male with a neopenis that is adapted for penetrativeintercourse. The distal tubular portion 1002 is implantable withintissue of the neophallus, and the first proximal portion 1004 isattachable to the pelvis to orient the distal tubular portion 1002 andthe newly constructed neopenis in a conformation that replicates theconformation of a natal male penis.

The neophallus implant 1000 is a prosthetic implant useful intrans-gender phalloplasty procedures or in reconstructive neopenisprocedures. Embodiments provide a single distal cylinder sized andadapted for implantation into the neophallus and a proximal portion (ortwo proximal portions) sized and adapted for attachment to one or bothof the descending pubic rami. This general structure is suitable toaccommodate both inflatable prosthetics and malleable prosthetics.

FIG. 57 is a schematic view of the neophallus implant 1000 implanted inand attached to a trans-male pelvis. The first proximal portion 1004 isattached to the descending pubic ramus on the right side of the patientand the transfer joint 1006 is attached to the pubic body near the pubicsymphysis. The distal tubular portion 1002 extends away from the pelvisat a non-zero and non-180 degree angle in a conformation that replicatesthe angle and conformation of the natal male penis on a male pelvis. Thetrans-male pelvis is a female pelvis that is associated with an archangle AA measured between the descending rami. The arch angle AA of thetrans-male pelvis is generally understood to be in a range from about75-105 degrees, with an arch angle AA of about 90 degrees considered tobe common. In contrast, the natal male pelvis has a narrower opening anda narrower arch angle of about 60 degrees. The body 1024 of the transferjoint 1006 has the bend 1026 that is selected to orient the distaltubular portion 1002 at a female pubic arch half angle HAA relative tothe first proximal portion 1004 to so adapt the implant 1000 to providethe trans-male pelvis with an implant that has a conformation of that ofthe natal male. This configuration improves the stability of theneophallus implant 1000 and better approximates the male proximal penilestructures of the natal male corpora cavernosa.

The first proximal portion 1004 is attachable to the ramus by suturingthe rear tip portion 1014 to the ramus with suture stitches, orattaching the first proximal portion 1004 to one of the implantablesupports described above. Alternatively, the surgeon may choose to wrapthe first proximal portion 1004 with an implantable fabric that securesthe first proximal portion 1004 to the descending pubic ramus.

FIG. 58 is a perspective view of one embodiment of a neophallus implant1050. The neophallus implant 1050 includes a distal tubular portion1052, a first proximal portion 1054, a second proximal portion 1056, anda transfer joint 1058 connected between the distal tubular portion 1052and the first and second proximal portions 1054, 1056. Embodiments of aneophallus implant 1050 provide a bifurcated set of proximal portionsthat communicate with the distal tubular portion 1052. In oneembodiment, the bifurcated neophallus implant 1050 is symmetric about alongitudinal axis centered on the distal tubular portion 1052.

In one embodiment, the distal tubular portion 1052 is provided as aninflatable penile prosthetic having a first inflatable cavity coupledalong a septum 1060 to a second inflatable cavity. In one embodiment,the distal tubular portion 1052 has one and only one inflatable cavity.The distal tubular portion 1052 is suitably provided as a single cavitythat is inflatable with liquid, or alternatively, with two inflatablecavities that are joined along the septum 1060. The distal tubularportion 1052 extends from the transfer joint 1058 to a distal endportion 1062. The distal tubular portion 1052 is adapted for insertioninto the neophallus tissue to provide the neophallus with an erectionthat is suitable for penetrative intercourse.

The natal male penis has a first (left side) corpus cavernosum and asecond (right side) corpus cavernosum, where the corpora cavernosa areseparated by a septum. Neither of the embodiments above (two inflatablecavities or a single cavity) are appropriate for implantation into anatal male because of the dual and separate nature of the natal malecorpora cavernosa could not receive the distal portion of the deviceinside of the penis. The natal male also has a pair of crura, and eachcrus diverges away from the midline of the patient in the proximaldirection and is attached to the ischiopubic ramus. The diverging natureof the crura prevents the natal male anatomy from receiving the unitizedfirst and second proximal portions 1054, 1056. Thus, the neophallusimplant 1050 is adapted for implantation into the trans-male anatomy andis not appropriate for implantation into the natal male anatomy.

The first proximal portion 1054 extends from a first rear tip portion1064 to the transfer joint 1058 and includes a liquid port 1066. Therear tip portion 1064 is adapted to secure the implant 1050 to thepelvis of a trans-male. The liquid port 1066 is configured forattachment to a reservoir holding a volume of liquid and a pump adaptedto move the liquid out of the reservoir. A suitable reservoir and asuitable pump are described above in FIG. 54 .

The second proximal portion 1056 extends from a second rear tip portion1074 to the transfer joint 1058 and includes a second liquid port 1076.The second liquid port 1076 is also configured for attachment to areservoir holding a volume of liquid and a pump adapted to move theliquid out of the reservoir. A suitable reservoir and a suitable pumpare described above in FIG. 54 .

The transfer joint 1058 includes a distal end 1080 coupled with thedistal tubular portion 1052, a first proximal end 1082 connected to thefirst proximal portion 1054, a second proximal end 1084 connected withthe second proximal portion 1056, and a fixed bend 1090 that isconfigured to orient the first proximal portion 1054 of the implant 1050at a pubic arch angle of 110 degrees or less relative to the secondproximal portion of the implant 1056. In one embodiment, the fixed bend1090 in the transfer joint 1058 has the effect of orienting the firstproximal portion 1054 at an angle in a range from 80-110 degreesrelative to the second proximal portion 1056, where this angle conformswith the generally wider female pubic arch of the trans-male pelvis. Incontrast, the natal male pelvis has a pubic arch angle of approximately60 degrees.

In one embodiment, a diameter of the distal tubular portion 1052 of theimplant 1050 is larger than a dimeter of the first proximal portion 1054and a diameter of the second proximal portion 1056. One effect of thisdiameter relationship is to provide the trans-male neopenis with anenhanced girth while also affording comfort along the internallyimplanted (and narrower diameter) proximal portions 1054, 1056.

In one embodiment, one or more attachment tabs 1086 is provided on oneor both of the proximal portions of the implant. In one exemplaryembodiment, attachment tabs 1086 are secured to a portion of thetransfer joint 1058, the second rear tip portion 1074, and at a locationbetween the transfer joint 1058 and the rear tip portion 1074. Thesurgeon will use the attachment tabs 1086 for securing the implant 1050to the tissue of the pelvis. In one embodiment, the attachment tabs 1086are provided with suture eyelets 1088 that are positioned to allow thesurgeon to suture the implant 1050 to the tissue structure of thepelvis. Although attachment tabs 1086 are illustrated on the secondproximal portion 1056, it is to be understood that embodiments includeattachment tabs provided on both of the proximal portions 1054, 1056 andalong at least two sides of the transfer joint 1058.

The neophallus implant 1050 is a Y-shaped penile prosthetic, where abody 1092 of the transfer joint 1058 includes the fixed bend 1090 thatis adapted to orient the distal tubular portion 1052 in the same orsimilar conformation of a natal male penis of the male pelvis. TheY-shaped penile prosthetic 1050 includes the first proximal portion 1054that is attachable to one of the descending pubic rami of the patient,and the second proximal portion 1056 that is attachable to another ofthe descending pubic rami of the patient, with the transfer joint 1058adapted to support and orient the distal tubular portion 1052 in acis-male orientation configured for penetrative intercourse.

The neophallus implants 1000, 1050 are suitably fabricated to be amonolithic, one-piece component. For example, the bifurcated neophallusimplant 1050 is fabricated from a single thin-walled polymer suitablyreinforced by the transfer joint 1058 to include the bifurcated angle.In an alternative embodiment, the neophallus implants 1000, 1050 aresuitably constructed from discrete components, for example an inflatabledistal portion coupled to the transfer joint, and a proximal portioncoupled to another side of the transfer joint, where the proximalportion is either inflatable, or a rigid malleable (non-inflatable)structure.

FIG. 59A illustrates one embodiment of implanting the Y-shapedneophallus implant 1050 (FIG. 58 ). In one embodiment, and implantationspace is created during the phalloplasty, where the implantation spaceis sized to receive the Y-shaped neophallus implant 1050 (FIG. 58 ) orthe Y-shaped neophallus implant 1120 (FIG. 60C). The surgeon may chooseto have a period of between several weeks to several months between thecreation of the phalloplasty and the implantation of the neophallusimplant. Embodiments described provide a method of maintaining the spacecreated during the phalloplasty to allow for implantation of one of thedescribed the neophallus implants into that space. This approach reducesor eliminates coring out (or dilation) of the neophallus. Dilating thetissue within the neophallus can give rise to undesirable outcomes suchas perforating the neourethra, damaging the nerves within theneophallus, or puncturing a wall of the neophallus.

In one embodiment, a place holder 1091 is implanted after formation ofthe neophallus. The place holder 1091 includes a first proximal portion1093 and a second proximal portion 1094 diverging from a body 1095. Thefirst proximal portion 1093 is sized and shaped to maintain a spacesized to receive the first proximal portion 1054 of the neophallusimplant 1050 (FIG. 58 ) and the second proximal portion 1095 is sizedand shaped to maintain a space sized to receive the second proximalportion 1056 of the neophallus implant 1050. The first and secondproximal portions 1054, 1056 of the neophallus implant 1050 aregenerally cylindrical, and embodiments of the place holder 1091 includea cylindrical shape for the first and second proximal portions 1093,1094. The body 1095 is a lateral dimension that is generally larger thanthe first and second proximal portions 1093, 1094 and is sized tomaintain a shape within the neophallus that will receive the increasedwith of the distal portion 1052 of the neophallus implant 1050. In someembodiments, the body 1095 has a rectangular cross-section, and in otherembodiments, the body 1095 has an oval or circular cross-sectionalsheet.

The surgeon implants the place holder 1091 into the trans-male pelvisafter forming the neophallus. In one embodiment, the surgeon connects anartificial crus penis recess 1096 to the descending ramus on thepatient's right hand side and a second artificial crus penis recess 1097to the descending ramus on the patient's left hand side. The firstproximal portion 1093 of the place holder 1091 is inserted into theartificial crus penis recess 1096 and the second proximal portion 1094of the place holder 1091 is inserted into the artificial crus penisrecess 1097. The body 1095 is inserted and implanted into theneophallus.

In one embodiment, the place holder 1091 is implanted into thetrans-male pelvis after forming the neophallus without the aid ofartificial recesses or attachment devices. For example, instructions areprovided directing the surgeon to dissect the tissue down to the musclethat is attached to each descending ramus and to subsequently form apocket with the subcutaneous tissue. The place holder 1091 is insertedinto the pockets formed under the subcutaneous tissue and over themuscle on the ramus, and into the neophallus. Thus, the artificial cruspenis recesses 1096, 1097 are optional.

The place holder 1091 reduces or eliminates the growth of tissue intothe space where the neophallus implant 1015 will be implanted. Afterimplantation of the place holder 1091, tissue will grow around the placeholder 1091 to form a tissue capsule in the shape of the place holder1091, which is also the shape of the neophallus implant 1050. Aftersuitable period for healing, the surgeon removes the place holder 1091to access the tissue capsule. The neophallus implant 1050 is insertedinto the tissue capsule, which is sized and shaped receive theneophallus implant 1050. The artificial crus penis recesses 1096, 1097are encapsulated in the tissue capsule to more closely represent thecrus penis recess of a natal male. The place holder 1091 obviates thetissue dilation that can lead to the undesirable consequences identifiedabove.

It is desirable that the tissue capsule form around the place holder1091 and not attach to the surface of the place holder 1091. Embodimentsinclude incorporating a tissue release complement under the place holder1091. Alternatively, the place holder 1091 is formed from silicone, towhich the tissue is unlikely to adhere.

FIG. 59B is a schematic view of another embodiment of an approach forimplanting the neophallus implant 1050 in a trans-male pelvis bysecuring the attachment tabs 1086 and the fabric 1089 to the trans-malepelvis. The first proximal portion 1054 is secured to the descendingramus on the right side of the patient and a second proximal portion1056 is secured to the descending ramus on the left side of the patient.Suitable approaches for connecting the proximal portions 1054, 1056include sutures placed through the rear tip portions 1064, 1074, forexample by employing the attachment tabs 1086, or any of the implantablesupports described above that provide an artificial crus penis recess.The first proximal portion 1054 has been secured to the descending ramuson the right side of the patient using the fabric 1089. The secondproximal portion 1056 has been secured to the descending ramus on theleft side of the patient by suturing through the attachment tabs 1086.The transfer joint 1058 is coupled to the first and second proximalportions 1054, 1056 and supports the distal tubular portion 1052 in aposition relative to the trans-male pelvis that mirrors the position ofthe penis of a cis-male. The liquid ports 1066, 1076 are attachable tothe liquid reservoir and the pump. The liquid reservoir is typicallyimplanted somewhere within the abdomen, and the pump is implanted in aneoscrotum.

In one exemplary embodiment, one or both proximal portions 1054, 1056are secured to a descending ramus with a fabric 1089 that is wrappedaround one or both of the proximal portions 1054, 1056 and secured tothe tissue of the pelvis. Suitable fabrics include synthetic meshfabrics that are porous and allow for tissue ingrowth. One suitablefabric is RESTORELLE® Flat Mesh available from Coloplast Corp.,Minneapolis, Minn. Another suitable fabric is the GORE-TEX® syntheticpermeable membrane available from W. L. Gore & Associates.

The transfer joint 1058 provides a Y-shaped transfer joint. Whenassembled as illustrated, the neophallus implant 1050 provides aY-shaped inflatable penile prosthetic. The neophallus implant 1050 isinflatable through the ports 1066, 1076. The Y-shaped geometry of theneophallus implant 1050 constrains movement of the implanted neophallussystem since the fixed bend 1090 is supported by tissue under and aroundthe fixed bend 1090. The support provided by the tissue under the fixedbend 1090 interferes with movement of the implanted neophallus system,one advantage of which is to provide resistance to the axial thrustassociated with penetrative intercourse. The tissue under the fixed bend1090 holds and supports the neophallus implant 1050 after implantationand healing by the patient.

FIG. 60A is a perspective view of one embodiment of the transfer joint1058. The transfer joint 1058 includes the body 1092 that extendsbetween the distal end 1080, the first proximal end 1082, and the secondproximal end 1084. In one embodiment, the transfer joint 1058 is aY-shaped joint for the body 1092 extends continuously between the distalend 1080 and the first and second proximal ends 1082, 1084 to providethe fixed bend 1090 that is selected to have a pubic arch angle adaptedto match the pubic arch angle of the trans-male pelvis.

FIG. 60B is a perspective view of one embodiment of a transfer joint1100. The transfer joint 1100 includes a distal end 1102, a firstproximal end 1104, and a second proximal end 1106. The transfer joint1100 includes a body 1108 that extends continuously between the distalend 1102 and the first and second proximal ends 1104, 1106. The transferjoint 1100 is configured as a Y-shaped transfer joint having a firstbranch 1112 oriented relative to a second branch 1114 by a fixed bend1116.

The distal end 1102 has a diameter that is sized to receive a distalpenile prosthetic. The first and second proximal ends 1104, 1106 eachhave a diameter that is sized to couple with a proximal portion. Thetransfer joint 1100 provides an implantable portion for a trans-malethat provides a wider girth distal penile prosthetic (as compared to thegirth of a penile prosthetic of a natal male that is sized to fit insideof a corpus cavernosum). The transfer joint 1100 has first and secondproximal ends 1104, 1106 that receive proximal portions of the implant,and it is desired that the proximal portions are fixated relative to thepubic body, or rami. In one embodiment, the diameter of the distal end1102 is larger than either diameter of the first and second proximalends 1104, 1106, one effect of which is to provide enhanced girth to thedistal portion of the implant and increased comfort of the proximalportions of the implant.

FIG. 60C is a schematic view of one embodiment of a neophallus implant1120 implanted in a trans-male pelvis. The neophallus implant 1120includes a distal portion 1122 coupled to the distal end 1102 of thetransfer joint 1100, a first proximal portion 1124 coupled to the firstproximal end 1104 of the transfer joint 1100, and a second proximalportion 1126 coupled to the second proximal end 1106 of the transferjoint 1100. At least the distal portion 1122 is an inflatable penileprosthetic and is inflated through the port 1128. The liquid port 1128is connected to one of the first proximal portion 1124 or the secondproximal portion 1126.

In one embodiment, the implant 1120 is monolithically formed as a singleunit to include the transfer joint 1100, the distal portion 1122, thefirst proximal portion 1124, and the second proximal portion 1126. Forexample, the distal portion is formed as a thin walled polymer sheetthat is connected to the transfer joint 1100, and the first and secondproximal portions, whether inflatable or not inflatable, are connectedto the proximal ends of the transfer joint 1100.

In one embodiment, the distal portion 1122 and the first and secondproximal portions 1124, 1126 are provided as tubular cylinders and areinflatable through the port 1128. The port 1128 is adapted to beattached to a reservoir at 1130 holding a volume of liquid and a pump at1130 provided to move the liquid out of and into the pump. One suitablepump P and one suitable reservoir R are described above in FIG. 3 andare available from Coloplast Corp., Minneapolis, Minn. In oneembodiment, the distal portion 1122 is inflatable through the port 1128and the first and second proximal portions 1124, 1126 are not inflatablebut are formed to have a solid cross-section having an interior channelformed in the solid portion, where the channel communicates between theport 1128 and the inflatable distal portion 1122.

In one embodiment, the distal portion 1122 is an inflatable penileprosthetic and the first and second proximal portions 1124, 1126 are notinflatable. In one embodiment, the distal portion 1122 of the implant1120 is an inflatable penile prosthetic having one and only oneinflatable cavity.

In one embodiment, the first and second proximal portions 1124, 1126 aresolid components having a circular lateral cross-sectional shape thattapers to a narrower proximal end. In this case, the port 1128 is movedin a distal direction and attached to one of the transfer joint 1100 orto the distal portion 1122. In one embodiment, the first and secondproximal portions 1124, 1126 have a flat profile that is rectangular incross-section, where the flat profile adapts the first and secondproximal portions 1124, 1126 to lay flat against the muscle that isattached to the ramus.

The transfer joint 1100 provides a Y-shaped transfer joint having thefirst branch 1112 oriented relative to the second branch 1114 by thefixed bend 1116. When assembled as illustrated, the neophallus implant1120 provides a Y-shaped inflatable penile prosthetic. The neophallusimplant 1120 is inflatable through a single port 1128, which is anadvantage over the dual port neophallus implant 1050 (FIG. 59B) sincefewer parts are employed. In one embodiment, the fixed bend 1116 in thetransfer joint 1100 orients the first proximal portion 1124 at an anglein a range from 80-110 degrees relative to the second proximal portion1126 to adapt the first proximal portion 1124 and the second proximalportion 1126 of the implant 1120 to align with a female pubic arch. Theangle is shown as a pubic arch angle for a trans-male pelvis. TheY-shaped geometry of the neophallus implant 1120 constrains movement ofthe implanted neophallus system since the fixed bend 1116 is supportedby tissue under and around the fixed bend 1116. The support provided bythe tissue (subcutaneous or perineal) under the fixed bend 1116interferes with movement of the implanted neophallus system, oneadvantage of which is to provide resistance to the axial thrustassociated with penetrative intercourse. One advantage of thistissue-style of support is that the attachment tabs 1086 (FIG. 59B) andthe fabric 1089 (FIG. 59B) is not used to achieve firm fixation. Oneeffect of adapting the neophallus implant 1120 to be implanted andsupported by the tissue within the fixed bend 1116 is that theimplantation procedure is simplified since no suture attachments orother fixation devices are used. If the surgeon determines that theneophallus implant 1120 should later be removed, there are no sutureattachments or other fixation devices to be cut or dissected. Theneophallus implant 1120 is implanted with the first and second proximalportions 1124, 1126 inserted into a tissue pocket alongside the ramiwithout using attachment devices or fixation. The tissue under the fixedbend 1116 holds and supports the neophallus implant 1120 within thetrans-male pelvis without sutures or fabric wraps.

One method of implantation includes forming a neophallus in aphalloplasty procedure. The neophallus implant 1120 is implanted in theneophallus by inserting the distal portion 1122 into the neophallus andinserting the first and second proximal portions 1124, 1126 alongsideeach ramus, respectively, between the muscle attached to the ramus andthe tissue over the muscle. The surgeon may dissect or dilate tissuealong each ramus to form a pocket that is sized to receive each of thefirst and second proximal portions 1124, 1126.

In an alternative method, a neophallus and the surgeon forms a tissuepocket over the muscle attached to each ramus and the tissue over themuscle. The place holder 1091 (FIG. 59A) is inserted into each of thetissue pockets and the neophallus, for example with each of the firstand second proximal portions 1093, 1094 located in one of the respectivetissue pockets and the distal portion 1095 located in the neophallus.The surgical site is allowed to heal. The surgeon surgically removes theplace holder 1091 to reveal openings formed in each tissue pocketalongside each ramus and within the neophallus. The neophallus implant1120 is inserted into the open tissue pockets with the first and secondproximal portions 1124, 1126 placed in the tissue pockets alongside ofeach descending ramus and the distal portion 1122 placed in the openingformed in the neophallus. The surgeon may opt to use a tool to push thefirst and second proximal portions 1124, 1126 into the tissue pocketsformed alongside of the rami. Suitable tools include blunt-styledpushing devices such as the flat blade Boyarskogo or Petrovsky tools. Asuitable tool for placing the distal portion 1122 includes the flatbladed pushing tools or a Furlow-style of device that employs a Keithneedle to place a penile prosthetic into penile tissue.

One aspect of the method includes forming the fixed bend 1116 in thetransfer joint 1100 at a pubic arch angle to align the first proximalportion 1124 of Y-shaped inflatable implant 1120 and the second proximalportion 1126 of Y-shaped inflatable implant with a pubic arch of thetrans-male pelvis.

The pump and reservoir 1130 are implanted, for example with the pumplocated in the neoscrotum and the reservoir implanted subcutaneously orinside of the abdomen. The pump and the reservoir are connected to theport 1128 and the distal portion 1122 of the neophallus implant 1120 isinflated to ensure appropriate operation of the implanted device. Thepatient is allowed to heal. The Y-shaped geometry of the neophallusimplant 1120 limits or prevents movement of the implanted neophallussystem (implant 1120 and pump/reservoir 1130) since the fixed bend 1116is supported by tissue under and around the fixed bend 1116. The supportprovided by the tissue (subcutaneous or perineal) under the fixed bend1116 interferes with movement of the implanted neophallus system, oneadvantage of which is to provide resistance to the axial thrustassociated with penetrative intercourse.

FIG. 61 is a partial cross-sectional view of one embodiment of aneophallus implant 1200. The neophallus implant 1200 includes aninflatable body 1202 and an artificial glans penis 1204 coupled to theinflatable body 1202. The inflatable body 1202 includes a wall 1206 thatdefines a cavity 1208. The pump P is operable to move liquid stored inthe reservoir R into the cavity 1208 to inflate the inflatable body1202. The liquid is retained in the reservoir and the illustration ofFIG. 61 such that the inflatable body 1202 is deflated. The inflatablebody 1202 includes a distal tip 1210 that is configured to move betweenan inverted shape, as illustrated, to an erect state. One suitable pumpP and a reservoir R are described above in FIG. 3 and is available fromColoplast Corp., Minneapolis, Minn.

The artificial glans penis 1204 includes a wall 1212 that defines acavity 1214. The wall 1212 includes an interior surface 1216 and anexterior surface 1218. The wall 1212 is folded on itself and theexterior surface 1218 is bonded to an exterior surface of the wall 1206to form a hem 1220. The artificial glans penis 1204 is separate from andsealed against the inflatable body 1202 such that the artificial glanspenis 1204 is not in fluid communication with the inflatable body 1202.

In one embodiment, the reservoir R is filled with saline or other liquidthat is movable by the pump P into and out of the inflatable body 1202.One suitable pump P and reservoir R are described above in FIG. 3 bothare available from Coloplast Corp., Minneapolis, Minn.

The cavity 1214 is filled with a liquid. In one embodiment, the cavity1214 is filled with a gel. When inflatable body 1202 is pressurized, thedistal tip 1210 moves into a portion of the cavity 1214 to displace aportion of the gel, which increases the firmness of the artificial glanspenis 1204. In this manner, the tumescence that occurs within the glanspenis of a natal male penis is artificially replicated in a neophallusimplant that is suitable for implantation into a trans-male. Onesuitable gel is a silicone gel. Other suitable gels include gels formedfrom hydrocolloids.

FIG. 62 is a partial cross-sectional view of the neophallus implant 1200after the liquid has been moved from the reservoir R into the inflatablebody 1202. The pressure inside of the cavity 1208 is thus increased,which results in an inflation and expansion of the wall 1206. Theexpansion of the wall 1206 causes the distal tip 1210 to move in adistal direction into the cavity 1214 of the artificial glans penis1204. The artificial glans penis 1204 becomes firm and forms a glanscorona adjacent to hem 1220. The firmness of the artificial glans penis1204 is controlled by controlling the pressure inside of the inflatablebody 1202, the elasticity of the wall 1204, the volume within the cavity1214, and the amount of expansion of the distal tip 1210 into theartificial glans penis 1204.

The artificial glans penis 1204 provides the means for reducing orpreventing erosion of a neophallus implant through a neophallus of atrans-male. The artificial glans penis 1204 provides the means forincreasing the girth of the distal portion of a neopenis implanted in atrans-male.

FIG. 63 is a partial cross-sectional view of one embodiment of aneophallus implant 1300. The neophallus implant 1300 includes aninflatable body 1302 coupled to an artificial glans penis 1304. Theinflatable body 1302 includes a wall 1306 that defines a liquidreceptacle, or cavity 1308, and terminates at a distal tip 1310. Theartificial glans penis 1304 is in fluid communication with theinflatable body 1302 by the valve 1312. The valve 1312 includes a ball1314 that is biased against a valve seat 1316 by a spring 1318. In oneembodiment, the valve 1312 is a check valve that includes a selectedcracking pressure. The pump P is operable to move liquid out of thereservoir R and into the inflatable body 1302 to thus increase thepressure within the cavity 1308. The cracking pressure of the valve 1312is selected to open within the pressure range of the inflation of theinflatable body 1302 to allow liquid to move from the cavity 1308 andinto the artificial glans penis 1304. In one embodiment, the inflatablebody 1302 is inflatable to a pressure in a range from 5-20 pounds persquare inch (34-138 kPa) and the cracking pressure is selected to be ofvalue that is less than the inflatable pressure within the cavity 1308.As one example, the inflatable body 1302 is inflatable to a pressure ofapproximately 15 pounds per square inch (103 kPa) and the crackingpressure of the valve 1312 is selected to be approximately 10 pounds persquare inch (69 kPa).

The artificial glans penis 1304 includes a wall 1320 defining a cavity1321, where the wall 1320 includes an interior surface 1322 and anexterior surface 1324. In one embodiment, the wall 1320 is folded onitself to form a hem 1326, for example by folding a portion of the wall1320 onto itself and sealing the interior surface 1322 to an exteriorsurface of the wall 1306. The neophallus implant 1300 is adapted forimplantation into the tissue of a neophallus, and an embodiment includesproviding the surgeon with a nub 1330 having a hole 1332 that allows thesurgeon to push or direct the artificial glans penis 1304 into a distalportion of the neophallus.

The artificial glans penis 1304 is in fluid communication with thecavity 1308. One consequence of this is that the neophallus implant 1300is self-contained and the artificial glans penis 1304 is eventuallyfilled with whatever liquid is employed to inflate the inflatable body1302. Thus, no fill port or other valve structure is needed to fill theartificial glans penis 1304 with liquid.

The artificial glans penis 1304 provides the means for reducing orpreventing erosion of a neophallus implant through a neophallus of atrans-male. The artificial glans penis 1304 provides the means forincreasing the girth of the distal portion of a neopenis implanted in atrans-male.

FIG. 64 is a perspective view of the neophallus implant 1300 inflatedwith liquid to provide an erection. The liquid contained in thereservoir R has been moved by the pump P into the inflatable body 1302.The increasing pressure in the inflatable body 1302 displaces the distaltip 1310 in a distal direction and delivers liquid through the valve1312 and into the artificial glans penis 1304. The pump P operates toinflate both the inflatable body 1302 and the artificial glans penis1304. The neophallus implant 1300 is adapted to be deflated to a flaccidstate, and during deflation of the inflatable body 1302 the pressureinside of the cavity 1321 will be reduced as the distal tip 1310inverts.

The artificial glans penis 1204 (FIG. 61 ) and 1304 (FIG. 63 ) areprovided in a dome shape that provides the distal end of the neophalluswith a firm and expandable artificial glans penis.

FIG. 65 is a partial cross-sectional view of one embodiment of aneophallus implant 1400. The neophallus implant 1400 includes aninflatable body 1402 coupled to an artificial glans penis 1404. Theinflatable body 1402 includes a wall 1406 that defines a cavity 1408 andterminates in a distal tip 1410. A nub 1412 is provided at the distaltip 1410 and includes a suture hole 1414 to facilitate implantation ofthe implant 1400 into a neophallus. The nub 1412 is coupled to a portionof the inflatable body 1402 to provide the surgeon with a familiarimplantation feature.

The artificial glans penis 1404 includes a wall that forms a cavity1421, where the wall 1420 is attached to the inflatable body 1402 at adistal seam 1422 and at a proximal seam 1424. The attachment of theartificial glans penis 1404 along the to seams 1422, 1424 forms agenerally annular shape that forms a suture channel 1426. The artificialglans penis 1404 is sealed such that the cavity 1421 is separated fromthe cavity 1408. The inflatable body 1402 is inflatable with liquidmoved by the pump P out of the reservoir R. Inflation of the inflatablebody 1402 will expand the distal tip 1410 and increase the pressurewithin the cavity 1421.

FIG. 66 is a partial cross-sectional view of the neophallus implant 1400inflated with liquid. The liquid has been moved from the reservoir Rinto the inflatable body 1402 by the pump P. The increased pressure inthe inflatable body 1402 displaces the distal tip 1410 in a distaldirection to subsequently displace the annular artificial glans penis1404 to form a glans corona. Expansion of the annular artificial glanspenis 1404 expands and opens the suture channel 1426 in a manner thatprotectively covers the nub 1412 by extending a longitudinal distancepast the nub 1412.

One method of providing a trans-male with a neopenis includes invertingthe vagina to create a neophallus. The method includes dissecting tissueto disconnect the internal organs (cervix, uterus) and connective tissuefrom the vagina to form a complete prolapse of the vagina. One stepincludes removing the cervix from the apex of the vagina. Alternatively,the cervix is not removed from the vagina and tissue from the cervix isshaped into a glans penis.

The tissue of the inverted vagina is employed, in whole or in part, toform the tissue of the neophallus. One of the neophallus implant systemsdescribed above, for example system 20, 300, 400, 600, 610, 620, 650, or700 is implanted within the trans-male with the penile prostheticimplanted within the neophallus, a pump implanted within the neoscrotum,and the reservoir implanted within the abdomen. In one embodiment, thereservoir is implanted within the internal space of the abdomen/pelvisthat was previously occupied by the vagina. One alternative step of themethod includes adding bulking material around the penile prosthetic toincrease the girth of the neopenis. Suitable bulking material includescadaver tissue, animal tissue, collagen, a collagen sponge, a mesh, abioabsorbable sponge, synthetic material, or a bioabsorbable material.In one embodiment, the bulking material is pre-shaped to receive thepenile prosthetic. In one embodiment, the method includes folding aninferior portion of the tissue of the inverted vagina unto itself (forexample, the anterior and interior wall of the vagina); closing aportion of the folded tissue to itself at an inferior (underneath)location; and thus forming a channel that is sized to receive a portionof the urethra or a portion of the neourethra of the trans-male, or botha portion of the urethra and a portion of the neourethra of thetrans-male.

Aspects of methods of providing a trans-male with a neopenis includeattaching an artificial crus penis recess to the tissue of the pelvis,and supporting the proximal portion of the penile prosthetic byinserting the proximal portion of the penile prosthetic into theartificial crus penis recess.

Aspects of methods of providing a trans-male with a neopenis includeforming a tissue pocket alongside of each descending ramus of thepelvis, and supporting the proximal portion of the penile prosthetic byinserting the proximal portion of the penile prosthetic into the tissuepocket.

Aspects of methods of providing a trans-male with a neopenis includeforming a glans penis at a distal end of the neopenis with tissue of acervix.

Aspects of methods of providing a trans-male with a neopenis includemetoidioplasty. Metoidioplasty is completed in two stages: testosteronetreatment followed by surgery. During the testosterone treatment, theclitoris responds by growing longer. During surgery, the surgeon seversthe ligament that holds the clitoris in place under the pubic body,resulting in “clitoral release” that allows the enlarged clitoris tohave the appearance of a small penis. The metoidioplasty is followed bythe release of the vagina and inversion of the vagina outside of thepelvis. In one embodiment, a portion of the enlarged clitoris issurgically transported to a distal portion of the inverted vagina toincrease sensitivity in this area of the neophallus. The trans-male hasa urethra that is approximately 2 cm long, and aspects of the methodincludes attaching a neourethra to the natal urethra to construct aneourethra through the neophallus.

The glans penis is formed at the distal portion of the inverted vagina,and can include aspects of the artificial glans penis structuresdescribed above, or additional tissue formed as a glans corona. A penileprosthetic is implanted within the inverted vagina and can includeaspects of the neophallus implant system described above, such as a pumpand a reservoir, to facilitate inflation of an inflatable penileprosthetic. The implanted penile prosthetic is secured to the pelvis ofa trans-male, for example using one of the artificial crus penisreceptacles described above. In this way, the implanted penileprosthetic is supported to resist the axial forces associated withpenetrative intercourse and is positioned to appropriately replicate theposition of the penis in a natal male.

One exemplary method of surgically creating a neopenis includesdissecting tissue away from a vagina to disconnect the vagina fromorgans and connective tissue inside of a pelvis; inverting the vaginaout of the pelvis to provide an inverted vagina by exposing an interiorwall of the vagina outside of the pelvis; inserting a penile prostheticinto the inverted vagina and inside a portion of the pelvis; andsupporting a proximal portion of the penile prosthetic by attaching theproximal portion of the penile prosthetic to the pelvis.

The method can include inserting a bulking material and the penileprosthetic into the inverted vagina.

The method can include removing a cervix by dissecting the cervix awayfrom the vagina.

The method can include removing tissue from a cervix and forming a glanspenis with the tissue removed from the cervix; and attaching the glanspenis to the inverted vagina.

The method can include folding a superior portion of tissue of theinverted vagina and closing the superior portion of tissue of theinverted vagina to a second portion of the inverted vagina thus forminga channel; and placing a portion of a urethra of the trans-male and aportion of a neourethra of the trans-male into the channel.

The method can include inserting a malleable and non-inflatable penileprosthetic into the inverted vagina and inside the portion of thepelvis; and attaching a proximal portion of the malleable andnon-inflatable penile prosthetic to a descending ramus of the pelvis.

The method can include inserting an inflatable penile prosthetic intothe inverted vagina and inside the portion of the pelvis; attaching aproximal portion of the inflatable penile prosthetic to a descendingramus of the pelvis; coupling a reservoir and a pump to the inflatablepenile prosthetic with tubing; and implanting the reservoir and the pumpinto the trans-male.

Although specific embodiments have been illustrated and described inthis disclosure, it will be appreciated by those of ordinary skill inthe art that a variety of alternate and/or equivalent implementationsmay be substituted for the specific embodiments shown and describedwithout departing from the scope of this disclosure. This application isintended to cover any adaptations or variations of the above-disclosedmedical devices. Therefore, it is intended that this invention islimited only by the claims and their equivalents.

The invention claimed is:
 1. A kit of parts including componentsimplantable in a patient to adapt a neopenis of the patient forpenetrative intercourse, the kit of parts comprising: an implantablesupport attachable to a descending pubic ramus, the implantable supportformed to comprise a first artificial crus receptacle; an implantablepenile prosthesis comprising a proximal end portion insertable into thefirst artificial crus receptacle and a distal end portion locatedopposite of the proximal end portion; and an artificial glans penisattachable to the distal end portion of the implantable penileprosthesis; wherein, when implanted, the implantable support orients theimplantable penile prosthesis and the artificial glans penis in ananatomically natal penis position that is adapted for penetrativeintercourse.
 2. The kit of parts of claim 1, wherein the implantablepenile prosthesis comprises an inflatable penile prosthesis attachableby tubing to a liquid reservoir and a pump.
 3. The kit of parts of claim1, wherein the implantable support further comprises a second artificialcrus receptacle and the implantable penile prosthesis further comprisesa first inflatable cylinder insertable into the first artificial crusreceptacle and a second inflatable cylinder insertable into the secondartificial crus receptacle, wherein the first inflatable cylinder andthe second inflatable cylinder are each attachable to a liquid reservoirand a pump.
 4. The kit of parts of claim 1, wherein the implantablepenile prosthesis comprises a malleable penile prosthesis comprising ametal core surrounded by a polymer, wherein the malleable penileprosthesis is bendable between an erect penis position and a flaccidpenis position.
 5. The kit of parts of claim 1, wherein the distal endportion of the implantable penile prosthesis comprises a glans-shapedbulb.
 6. The kit of parts of claim 1, wherein the implantable supportfurther comprises a second artificial crus receptacle spaced a distanceaway from the first artificial crus receptacle.
 7. The kit of parts ofclaim 1, wherein the implantable support further comprises a mesh gridadapted for tissue in-growth relative to the implantable support.
 8. Thekit of parts of claim 1, wherein the implantable support furthercomprises a steel plate adapted to provide the implantable support withrigidity.
 9. A kit of parts including components implantable in apatient to adapt a neopenis of the patient for penetrative intercourse,the kit of parts comprising: an implantable support attachable to adescending pubic ramus, the implantable support formed to comprise afirst artificial crus receptacle; an inflatable penile prosthesiscomprising a proximal end portion insertable into the first artificialcrus receptacle, a distal end portion located opposite of the proximalend portion, and tubing connected to the inflatable penile prosthesisthat is attachable to a pump; and an artificial glans penis attachableto the distal end portion of the inflatable penile prosthesis; wherein,when implanted, the implantable support orients the inflatable penileprosthesis and the artificial glans penis in an anatomically natal penisposition that is adapted for penetrative intercourse.
 10. The kit ofparts of claim 9, wherein the implantable support further comprises asecond artificial crus receptacle and the inflatable penile prosthesisfurther comprises a first inflatable cylinder insertable into the firstartificial crus receptacle and a second inflatable cylinder insertableinto the second artificial crus receptacle, wherein the first inflatablecylinder and the second inflatable cylinder are each attachable to thepump.